Acetaminophen Extended Release Oral Tablet

Brand(s)
Mapap, Rx-Act Pain Relief, Tylenol
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division (2015-04-09)
Oldest Current Product
1991-04-15
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\ACETAMINOPHEN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ACETAMINOPHEN
SPL Active
ORAL\TABLET, EXTENDED RELEASE\ACETAMINOPHEN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\ACETAMINOPHEN
ORAL\TABLET\ACETAMINOPHEN
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\ACETAMINOPHEN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\ACETAMINOPHEN
ORAL\TABLET\ACETAMINOPHEN

product(s) by strength(s)

8 hr acetaminophen 650 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1505800783TylenolNDAJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2015-07-13ACETAMINOPHENORALTABLET, EXTENDED RELEASENDA0198723af22fc8-e4e0-4863-8696-6bc1257047cb

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130217ANDAL. Perrigo Company2006-02-13ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750774ecf0ac9-fe65-4c5f-8471-225af6f968cd
2001130544ANDAL. Perrigo Company2005-11-21ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077236eedd4-6ece-46ce-9ab3-12366d57126b
3003630217ANDAWalgreens1991-04-15ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077bba0b6cd-4573-4625-94d3-c02dadc9cf44
4003630334ANDAWalgreens2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762009908f235-ccbf-42d8-98d9-072b3cfc794a
5003630336ANDAWalgreens2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620063be92a2-5093-4971-a193-4c1672350b1a
6003630340ANDAWalgreens2012-12-21ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA078569a1cec332-5802-4684-8b7f-6cb98da40e8b
7003630544ANDAWalgreens2000-05-26ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750775028c116-d0e3-4e30-8fa8-caaf08d99ec7
8009045769MapapANDAMajor2006-02-16ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507761f212a4-3748-4782-95ce-5434f931b4f4
9116730210ANDATarget Corp2015-03-06ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750779dd97b25-b0d3-4b87-b014-453dbf4a72b7
10116730544ANDATarget Corp2009-06-23ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077d8fc6698-8d66-4ce9-bd29-0abbe111e8be
11116730608ANDATarget Corp2009-06-23ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077099ccc52-54a0-43bf-b4a2-52f0d3917536
12116730966ANDATarget Corp2015-03-18ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077842bf57f-cbd0-49c4-8c02-80f970ce0fc3
13118220217ANDARite Aid2013-09-21ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750776008a714-bd22-42c2-a101-0581595351f4
14118220544ANDARite Aid2013-09-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077e2bb2925-4fc7-4597-8d0c-768a48d8e4f1
15151270332ANDASelect Brand2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620080310ab1-f10f-4881-b31a-fa156db8e474
16211300217ANDABetter Living Brands Llc2010-11-22ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077fd658f54-4efd-4b40-877b-f51eb6abcfe3
17211300336ANDABetter Living Brands Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620067b2b4c0-4a2f-4952-8a88-3616d0185941
18211300760ANDABetter Living Brands Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762000eb865a6-229e-452d-a6a9-eb213018d192
19243850001ANDAGood Neighbor Pharmacy2005-08-31ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507756dd4269-4c74-4815-927d-1ee4b38f59f7
20243850629ANDAGood Neighbor Pharmacy2008-11-03ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077b6248c8f-d2de-4330-8ae7-1ee46bd0a19a
21301420217ANDAKroger2005-08-16ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077abbb8d6b-0a99-4d04-97f1-9f76fb689b34
22301420313ANDAKroger2014-05-19ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507705ff95ab-ef1d-44f7-863e-3d6c6458af0b
23301420544ANDAKroger2000-06-06ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507786208a98-36a8-4d0b-ba4e-b974ad478067
24301420966ANDAKroger2008-03-11ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077620abbe6-8485-4cd2-ae4b-901c6968824b
25368000217ANDATop Care (Topco Associates Llc)2005-11-29ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077407039ec-9006-4cff-9375-e6ebe5a8ec9b
26368000228ANDATop Care (Topco Associates Llc)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762002c7f99d4-b0c9-4094-9969-dcb8d04717a4
27368000404ANDATop Care (Topco Associates Llc)2007-08-20ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507767eba5e6-41e8-44f7-859f-edf0cfe7d5ce
28368000544ANDATop Care (Topco Associates Llc)2005-08-04ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077c7c67069-df0e-41e8-b792-d277559bd40e
29368000966ANDATop Care (Topco Associates Llc)2007-08-20ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077dd7eda5e-67ca-40db-a20d-6b7d460990b6
30370120333ANDAShopko Stores Operating Co, Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762005f564d84-7a62-4d84-af94-3262c707269f
31370120544ANDAShopko Stores Operating Co, Llc2013-10-02ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750771a952e86-25f3-46df-8d46-0139d3aad015
32372050034ANDACardinal Health2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200684f4800-66b1-4add-bb91-75d8bc12d98c
33372050477ANDACardinal Health2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762007466de2f-72ad-41cd-aaeb-e74d0c169254
34372050662ANDACardinal Health2012-12-21ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA078569a05a93b7-e132-4289-9d58-c1a6b9c1c1d6
35378080217Rx-Act Pain ReliefANDAH-E-B2005-10-01ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507748e1a103-5ac8-4510-8dac-423392aa7bf3
36378080333ANDAH-E-B2002-04-30ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA076200a67ea2d8-b415-4468-9e7a-bae4172428a0
37378080455ANDAH-E-B2005-10-01ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077fb307bc5-cb8b-49ea-878e-980ac5707436
38411630333ANDASupervalu, Inc2004-11-22ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762004b87c77f-3192-4fb5-9388-d71806e8f33e
39411630336ANDASupervalu, Inc2013-08-13ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620080c990c4-53f4-4102-b99b-f19bc895e5cb
40411630544ANDASupervalu, Inc2012-08-29ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077304b9639-a491-4fb1-9656-b8561eafa1d1
41411900544ANDAWakefern Food Corporation2013-08-06ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077166dc2f2-c042-41b1-a0a1-b5ac5b829ce9
42412500217ANDAMeijer Distribution, Inc2005-03-26ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507742575c96-3690-4b41-8861-c733546410a3
43412500544ANDAMeijer Distribution, Inc2005-03-26ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077251c9d15-665a-4828-8240-c5fdeb4e0484
44412500966ANDAMeijer Distribution, Inc2007-09-05ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077c388f3a5-03bb-4fed-b81a-bb876bc260f0
45412680544ANDAHannaford Brothers Company2000-06-23ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507778e747d0-3b1b-49b5-b12a-76e747658d79
46415200217ANDAFoodhold U.S.A., Llc2005-11-29ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077b3c76014-8783-4025-b459-85e070094b04
47415200333ANDAFoodhold U.S.A., Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200bfaa0ee9-37be-431f-a19d-2a4f3f7b3108
48415200336ANDAFoodhold U.S.A., Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200d8259f15-ef0f-41bf-a038-0be4eacb2d79
49415200544ANDAFoodhold U.S.A., Llc2005-11-22ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077c5865a69-4fe4-4f0d-9e03-5927dd737445
50415200966ANDAFoodhold U.S.A., Llc2009-12-15ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077aef4fb40-0c1f-442d-9291-d06b024ce4c8
51425070217ANDAHy-Vee2005-09-23ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750774e6965c9-b18e-4667-bb5f-92b9b44b024a
52425070544ANDAHy-Vee2005-11-06ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507702dd52f1-b110-4753-9703-6c78b712a946
53425070966ANDAHy-Vee2008-07-20ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077da0e73c5-9d27-4343-8c28-9ff31e4b360e
54461220062ANDAAmerisource Bergen2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200c0f4d7f1-aa17-4233-bc47-41c280fdd7ce
55461220170ANDAAmerisource Bergen2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620071be6a5b-aff2-4757-804a-085b44e2a7d3
56490350350ANDAWalmart2013-08-05ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA0785693f2e66eb-9838-41e9-be12-a73bdeb8cfa5
57490350407ANDAWalmart2011-07-19ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077e2a34e69-30f9-4739-ad03-16d0c584a5e5
58490350544ANDAWalmart2000-05-16ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077baac3c00-a651-4fd8-92f8-d790f1d0b1b7
59493480704ANDASunmark2008-02-13ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077361ab8b3-002a-4754-bdc3-4a640c7a561f
60493480705ANDASunmark2005-08-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750772bcb711c-7ac0-4f32-a5e5-b7e802c8a666
61493480921ANDASunmark2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200de777010-7f61-4ee1-96a8-4c9bc3b6c514
62493480924ANDASunmark2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200ab6401f9-9310-40dd-8f15-0d7199e27925
63496140473ANDAMedicine Shoppe International Inc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762004059ab71-24fd-43dc-a9c9-c43956f5901f
64497380217ANDAKmart Corp2010-10-22ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077bcaa4b41-6ad4-49c2-b5d3-b8e9653a6da6
65497380544ANDAKmart Corp2010-09-09ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507757262049-f196-4c00-9c75-c2c554f9cfa1
66497380966ANDAKmart Corp2010-10-14ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750779cac9a13-95c1-49f0-8a7c-4ba020398a94
67497810062ANDACardinal Health, Inc.2014-01-23ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077b1d78d9a-81d6-4f24-a076-f627f748cdab
68497810063ANDACardinal Health, Inc.2014-01-23ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077f70fcaa4-da00-47d3-872c-d6220090c02d
69516600333ANDAOhm Laboratories Inc.2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620038b01bef-4743-4a25-b5c9-99f12133f373
70516600336ANDAOhm Laboratories Inc.2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620088b55c5b-5a82-4ff6-98e9-0b402c40c46b
71516600340ANDAOhm Laboratories Inc.2012-12-21ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA078569bb95cfad-47ae-4be7-919e-3ae4664460c4
72533290643ANDAMedline Industries, Inc.2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762009f18d455-55ce-482c-8da8-dcb664038c6c
73553120217ANDAWestern Family2005-11-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750776bd4d762-c9d3-4308-bfa7-cb5f43c77a4f
74553120544ANDAWestern Family2006-03-20ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750778009d3bb-8bf2-46bb-83dc-0f375f1eb137
75553150333ANDAFreds Inc2004-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200070569ec-82b1-4b26-b38b-3fb3caf71f19
76553160544ANDADza Brands,2008-05-05ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077178beccd-422c-4c09-97ac-e33611f1dd53
77553160966ANDADza Brands,2013-05-16ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077659e4c9d-6f5a-44e1-b542-0da533df3a3b
78553190333ANDAFamily Dollar (Family Wellness)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200c65ef88a-ec37-4d61-8420-17f4807ac93a
79559100217ANDADolgencorp, Llc2010-01-05ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077ca7217be-6927-4752-bc18-0fb423fb591c
80559100435ANDADolgencorp, Llc2015-08-17ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077fd5db3a6-efa2-4e8a-9783-a7b6e6701c58
81559100544ANDADolgencorp, Llc2010-01-29ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077f11519c4-9906-4826-8b98-b05b408369bc
82559100966ANDADolgencorp, Llc2013-07-31ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077274958b6-304f-4f17-8f1f-a5528412c440
83560620544ANDAPublix Super Markets, Inc2007-11-26ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077af407852-5476-421d-a80a-d726c24b6391
84597790217ANDACvs2008-08-27ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507759e6b48b-ad5e-4c96-af1a-e2e10022256b
85597790336ANDACvs2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620090461bb3-a28e-4d34-b013-6a7981b338c7
86597790340ANDACvs2014-02-14ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA078569b57e5a38-ff6a-4e72-b5e3-3952d785f825, e0aa4c5d-88c0-4484-9185-f33888421dd3
87597790350ANDACvs2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620095db8167-ccae-44d1-b2e6-76d68bad9eba
88597790544ANDACvs2000-05-31ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750771526cd5e-8039-4a7e-94e8-b77d901b6d0f
89617150104ANDAPreferred Plus (Kinray)2014-09-22ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750777b31bea8-1050-4afa-a4e0-816a6074e4e0
90620110026ANDAMckesson (Health Mart)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200b8373c83-6e2a-4dec-a242-e442b9653ff5
91638680089ANDAQuality Choice (Chain Drug Marketing Association)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200fe4e9ec5-fa9c-4494-8516-ab477e0fa918
92638680091ANDAQuality Choice (Chain Drug Marketing Association)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200ded10c13-8a4e-469d-8b34-0d6566be016c
93639410333ANDABest Choice (Valu Merchandisers Company)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200793a6fa6-4ff0-498f-ae1b-71bcafb1fd73
94639410336ANDABest Choice (Valu Merchandisers Company)2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA076200b5ddc01d-40dc-400a-8a58-1e3a97d15142
95639810544ANDACostco Wholesale Company2013-01-18ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077c21f0f3f-fb2c-43d1-80d0-3a80a157c792
96680160333ANDAChain Drug Consortium, Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620056fbd149-8a82-4efb-b9e3-f865df4ae247
97680160336ANDAChain Drug Consortium, Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07620064fa67b4-b143-4789-a472-af047647a75e
98680160340ANDAChain Drug Consortium, Llc2012-12-21ACETAMINOPHENORALTABLET, EXTENDED RELEASEANDA078569e12098ad-8af1-45f3-817a-62dda19a9449
99681960463ANDASam'S West, Inc2012-01-28ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA07507767d4b98a-ea17-4443-aac3-37736ece0992
100681960544ANDASam'S West, Inc2005-08-31ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750771c225a56-0725-4b22-b9df-13a60212d6e2
101683910544ANDABjwc2008-04-28ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA075077c0c4d567-4d3a-4eef-bd90-6e5b01f256ea
102683910669ANDABjwc2014-05-08ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASEANDA0750774bda0989-5161-49a8-970f-16a30a024eef

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157590ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2000-02-25ACETAMINOPHENORALTABLET009045769ANDA07507761c8503f-96d7-483b-8832-3494d9cf07c6
2332610665ANDAAidarex Pharmaceuticals Llc2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASE516600333ANDA07620024837136-b72b-4c93-9b4e-7b6d1c6d18cc
3636295036ANDABryant Ranch Prepack2008-11-03ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASE243850629ANDA075077dd7b5ba3-652a-443f-b0b9-17abda148e67
4663360233ANDADispensing Solutions, Inc.2002-04-30ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASE516600333ANDA07620014a9db65-6d7b-4b06-ae03-93988ccc141d
5680840777ANDAAmerican Health Packaging2014-08-27ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASE516600333ANDA076200ac5b24a4-39a8-4c8a-b293-5f59966fb444
6762370282MapapANDAMckesson Contract Packaging2013-04-09ACETAMINOPHENORALTABLET, FILM COATED, EXTENDED RELEASE009045769ANDA07507712049b80-7800-4f13-a799-45009661b8d1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075077ACETAMINOPHENL PERRIGO CO2000-02-25ANDA075077_001
2ANDA076200ACETAMINOPHENOHM LABORATORIES INC2002-03-19ANDA076200_001
3ANDA078569ACETAMINOPHENSUN PHARMACEUTICAL INDUSTRIES LTD2011-12-14ANDA078569_001
4ANDA090205ACETAMINOPHENTrueSUN PHARMACEUTICAL INDUSTRIES LTD2009-11-18ANDA090205_001
5NDA019872TYLENOL JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1994-06-08NDA019872_001, NDA019872_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA075077_001OTCACETAMINOPHEN (650MG)ORALTABLET, EXTENDED RELEASEFalse2000-02-25ACETAMINOPHEN
2ANDA076200_001OTCACETAMINOPHEN (650MG)ORALTABLET, EXTENDED RELEASEFalse2002-03-19ACETAMINOPHEN
3ANDA078569_001OTCACETAMINOPHEN (650MG)ORALTABLET, EXTENDED RELEASEFalse2011-12-14ACETAMINOPHEN
4ANDA090205_001discontinuedACETAMINOPHEN (650MG)ORALTABLET, EXTENDED RELEASEFalse2009-11-18ACETAMINOPHEN
5NDA019872_001OTCACETAMINOPHEN (650MG)ORALTABLET, EXTENDED RELEASETrue1994-06-08TYLENOL
6NDA019872_002OTCACETAMINOPHEN (650MG)ORALTABLET, EXTENDED RELEASETrue2001-01-11TYLENOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102dd52f1-b110-4753-9703-6c78b712a946 (view SPL)Hy-Vee, Inc. Arthritis Pain Relief Drug FactsotcHuman OTCHy-Vee2015-03-053425070544
205ff95ab-ef1d-44f7-863e-3d6c6458af0b (view SPL)Kroger Co. Acetaminophen Drug FactsotcHuman OTCKroger2015-01-062301420313
3070569ec-82b1-4b26-b38b-3fb3caf71f19 (view SPL)Drug FactsotcHuman OTCFreds Incmanufacture2013-01-091553150333
4099ccc52-54a0-43bf-b4a2-52f0d3917536 (view SPL)Target Corporation Acetaminophen Extended-Release Tablets Drug FactsotcHuman OTCTarget Corp2014-02-132116730608
50eb865a6-229e-452d-a6a9-eb213018d192 (view SPL)Drug FactsotcHuman OTCBetter Living Brands Llcmanufacture2012-09-262211300760
612049b80-7800-4f13-a799-45009661b8d1 (view SPL)Major Pharmaceuticals Mapap Arthritis Pain Drug FactsotcHuman OTCMckesson Contract PackagingREPACK2013-04-091762370282
714a9db65-6d7b-4b06-ae03-93988ccc141d (view SPL)Drug FactsotcHuman OTCDispensing Solutions, Inc.relabel, repack2013-07-232663360233
81526cd5e-8039-4a7e-94e8-b77d901b6d0f (view SPL)CVS Pharmacy, Inc. Arthritis Pain Relief Drug FactsotcHuman OTCCvs2015-10-154597790544
9166dc2f2-c042-41b1-a0a1-b5ac5b829ce9 (view SPL)ShopRite Arthritis Pain Drug FactsotcHuman OTCWakefern Food Corporation2015-03-052411900544
10178beccd-422c-4c09-97ac-e33611f1dd53 (view SPL)DZA Brands, LLC Arthritis Pain Relief Drug FactsotcHuman OTCDza Brands,2015-01-273553160544
111a952e86-25f3-46df-8d46-0139d3aad015 (view SPL)Shopko Arthritis Pain Drug FactsotcHuman OTCShopko Stores Operating Co, Llc2015-01-272370120544
121c225a56-0725-4b22-b9df-13a60212d6e2 (view SPL)Sam's West, Inc. Arthritis Pain Drug FactsotcHuman OTCSam'S West, Inc2015-07-143681960544
13236eedd4-6ece-46ce-9ab3-12366d57126b (view SPL)Perrigo Arthritis Pain Drug FactsotcHuman OTCL. Perrigo Company2015-01-274001130544
1424837136-b72b-4c93-9b4e-7b6d1c6d18cc (view SPL)Drug FactsotcHuman OTCAidarex Pharmaceuticals Llc2013-11-121332610665
15251c9d15-665a-4828-8240-c5fdeb4e0484 (view SPL)Meijer Distribution, Inc. Arthritis Pain Relief Drug FactsotcHuman OTCMeijer Distribution, Inc2015-03-054412500544
16274958b6-304f-4f17-8f1f-a5528412c440 (view SPL)Dolgencorp, LLC Arthritis Pain Drug FactsotcHuman OTCDolgencorp, Llc2015-02-062559100966
172bcb711c-7ac0-4f32-a5e5-b7e802c8a666 (view SPL)McKesson 8 Hour Pain Relief Drug FactsotcHuman OTCSunmark2010-01-071493480705
182c7f99d4-b0c9-4094-9969-dcb8d04717a4 (view SPL)Drug FactsotcHuman OTCTop Care (Topco Associates Llc)manufacture2012-08-231368000228
19304b9639-a491-4fb1-9656-b8561eafa1d1 (view SPL)SuperValu Inc. Arthritis Pain Relief Drug FactsotcHuman OTCSupervalu, Inc2015-01-274411630544
20361ab8b3-002a-4754-bdc3-4a640c7a561f (view SPL)McKesson Arthritis Pain Relief Drug FactsotcHuman OTCSunmark2011-10-052493480704
2138b01bef-4743-4a25-b5c9-99f12133f373 (view SPL)Drug FactsotcHuman OTCOhm Laboratories Inc.manufacture2014-05-073516600333
223af22fc8-e4e0-4863-8696-6bc1257047cb (view SPL)TYLENOL 8 HR ARTHRITIS PAINotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2015-04-091505800783
233f2e66eb-9838-41e9-be12-a73bdeb8cfa5 (view SPL)Drug FactsotcHuman OTCWalmartmanufacture2013-06-201490350350
244059ab71-24fd-43dc-a9c9-c43956f5901f (view SPL)Drug FactsotcHuman OTCMedicine Shoppe International Incmanufacture2012-04-022496140473
25407039ec-9006-4cff-9375-e6ebe5a8ec9b (view SPL)Topco Associates LLC. 8 Hour Pain Relief Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2015-02-244368000217
2642575c96-3690-4b41-8861-c733546410a3 (view SPL)Meijer Distribution, Inc. Pain Relief Drug FactsotcHuman OTCMeijer Distribution, Inc2010-01-071412500217
2748e1a103-5ac8-4510-8dac-423392aa7bf3 (view SPL)HEB Pain Relief 8 HR Drug FactsotcHuman OTCH-E-B2010-01-071378080217
284b87c77f-3192-4fb5-9388-d71806e8f33e (view SPL)Drug FactsotcHuman OTCSupervalu, Incmanufacture2013-09-051411630333
294bda0989-5161-49a8-970f-16a30a024eef (view SPL)BJWC Arthritis Pain Relief Drug FactsotcHuman OTCBjwc2015-05-142683910669
304e6965c9-b18e-4667-bb5f-92b9b44b024a (view SPL)Hy-Vee, Inc. 8 Hour Pain Relief Drug FactsotcHuman OTCHy-Vee2015-02-243425070217
314ecf0ac9-fe65-4c5f-8471-225af6f968cd (view SPL)Perrigo Pain Relief Drug FactsotcHuman OTCL. Perrigo Company2015-02-243001130217
325028c116-d0e3-4e30-8fa8-caaf08d99ec7 (view SPL)Walgreen Co. Arthritis Pain Reliever Drug FactsotcHuman OTCWalgreens2015-08-076003630544
3356dd4269-4c74-4815-927d-1ee4b38f59f7 (view SPL)Amerisource Bergen 8 Hour Pain Relief Drug FactsotcHuman OTCGood Neighbor Pharmacy2010-01-071243850001
3456fbd149-8a82-4efb-b9e3-f865df4ae247 (view SPL)Drug FactsotcHuman OTCChain Drug Consortium, LlcMANUFACTURE2015-10-074680160333
3557262049-f196-4c00-9c75-c2c554f9cfa1 (view SPL)Kmart Corporation Arthritis Pain Relief Drug FactsotcHuman OTCKmart Corp2015-10-154497380544
3659e6b48b-ad5e-4c96-af1a-e2e10022256b (view SPL)CVS Pharmacy, Inc. Pain Relief Drug FactsotcHuman OTCCvs2015-10-153597790217
375f564d84-7a62-4d84-af94-3262c707269f (view SPL)Drug FactsotcHuman OTCShopko Stores Operating Co, Llcmanufacture2013-03-251370120333
386008a714-bd22-42c2-a101-0581595351f4 (view SPL)Rite Aid Corporation Acetaminophen 8 Hour Pain Relief Drug FactsotcHuman OTCRite Aid2015-01-062118220217
3961c8503f-96d7-483b-8832-3494d9cf07c6 (view SPL)Acetaminophen ER 650mgotcHuman OTCNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-08-1114006157590
4061f212a4-3748-4782-95ce-5434f931b4f4 (view SPL)Major Pharmaceuticals Mapap Arthritis Pain Drug FactsotcHuman OTCMajor2015-02-173009045769
41620abbe6-8485-4cd2-ae4b-901c6968824b (view SPL)Kroger Co. Arthritis Pain Relief Drug FactsotcHuman OTCKroger2015-03-054301420966
4263be92a2-5093-4971-a193-4c1672350b1a (view SPL)Drug FactsotcHuman OTCWalgreensMANUFACTURE2015-06-012003630336
4364fa67b4-b143-4789-a472-af047647a75e (view SPL)Drug FactsotcHuman OTCChain Drug Consortium, Llcmanufacture2012-07-132680160336
44659e4c9d-6f5a-44e1-b542-0da533df3a3b (view SPL)DZA Brands, LLC Arthritis Pain Relief Drug FactsotcHuman OTCDza Brands,2015-02-062553160966
4567b2b4c0-4a2f-4952-8a88-3616d0185941 (view SPL)Drug FactsotcHuman OTCBetter Living Brands Llcmanufacture2012-09-241211300336
4667d4b98a-ea17-4443-aac3-37736ece0992 (view SPL)Sams West, Inc. Arthritis Pain Drug FactsotcHuman OTCSam'S West, Inc2015-02-173681960463
4767eba5e6-41e8-44f7-859f-edf0cfe7d5ce (view SPL)Topco Associates LLC. Arthritis Pain Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2015-02-063368000404
48684f4800-66b1-4add-bb91-75d8bc12d98c (view SPL)Drug FactsotcHuman OTCCardinal Healthmanufacture2012-03-162372050034
496bd4d762-c9d3-4308-bfa7-cb5f43c77a4f (view SPL)Western Family Acetaminophen 8 HR Tablets 650mg Drug FactsotcHuman OTCWestern Family2015-04-233553120217
5071be6a5b-aff2-4757-804a-085b44e2a7d3 (view SPL)Drug FactsotcHuman OTCAmerisource Bergenmanufacture2012-10-311461220170
517466de2f-72ad-41cd-aaeb-e74d0c169254 (view SPL)Drug FactsotcHuman OTCCardinal Healthmanufacture2012-03-152372050477
5278e747d0-3b1b-49b5-b12a-76e747658d79 (view SPL)Hannaford Bros. Co. Arthritis Pain Relief Drug FactsotcHuman OTCHannaford Brothers Company2011-03-281412680544
53793a6fa6-4ff0-498f-ae1b-71bcafb1fd73 (view SPL)Drug FactsotcHuman OTCBest Choice (Valu Merchandisers Company)manufacture2013-01-281639410333
547b31bea8-1050-4afa-a4e0-816a6074e4e0 (view SPL)Kinray, LLC Arthritis Pain Drug FactsotcHuman OTCPreferred Plus (Kinray)2015-03-113617150104
558009d3bb-8bf2-46bb-83dc-0f375f1eb137 (view SPL)Western Family Acetaminophen Extended-Release Tablets 650 mg Drug FactsotcHuman OTCWestern Family2015-03-053553120544
5680310ab1-f10f-4881-b31a-fa156db8e474 (view SPL)Drug FactsotcHuman OTCSelect Brandmanufacture2012-10-021151270332
5780c990c4-53f4-4102-b99b-f19bc895e5cb (view SPL)Drug FactsotcHuman OTCSupervalu, Incmanufacture2013-09-051411630336
58842bf57f-cbd0-49c4-8c02-80f970ce0fc3 (view SPL)Target Corporation Acetaminophen Drug FactsotcHuman OTCTarget Corp2015-04-231116730966
5986208a98-36a8-4d0b-ba4e-b974ad478067 (view SPL)Kroger Co. Arthritis Pain Relief Drug FactsotcHuman OTCKroger2015-02-175301420544
6088b55c5b-5a82-4ff6-98e9-0b402c40c46b (view SPL)Drug FactsotcHuman OTCOhm Laboratories Inc.manufacture2012-05-242516600336
6190461bb3-a28e-4d34-b013-6a7981b338c7 (view SPL)Drug FactsotcHuman OTCCvsmanufacture2013-03-071597790336
6295db8167-ccae-44d1-b2e6-76d68bad9eba (view SPL)Drug FactsotcHuman OTCCvsmanufacture2013-01-211597790350
639908f235-ccbf-42d8-98d9-072b3cfc794a (view SPL)Drug FactsotcHuman OTCWalgreensMANUFACTURE2015-06-023003630334
649cac9a13-95c1-49f0-8a7c-4ba020398a94 (view SPL)Kmart Corporation Arthritis Pain Relief Drug FactsotcHuman OTCKmart Corp2013-01-242497380966
659dd97b25-b0d3-4b87-b014-453dbf4a72b7 (view SPL)Target Corporation Arthritis Pain Relief Drug FactsotcHuman OTCTarget Corp2015-04-162116730210
669f18d455-55ce-482c-8da8-dcb664038c6c (view SPL)Drug FactsotcHuman OTCMedline Industries, Inc.manufacture2013-03-221533290643
67a05a93b7-e132-4289-9d58-c1a6b9c1c1d6 (view SPL)Drug FactsotcHuman OTCCardinal Healthmanufacture2013-01-161372050662
68a1cec332-5802-4684-8b7f-6cb98da40e8b (view SPL)Drug FactsotcHuman OTCWalgreensMANUFACTURE2015-04-282003630340
69a67ea2d8-b415-4468-9e7a-bae4172428a0 (view SPL)Drug FactsotcHuman OTCH-E-BMANUFACTURE2014-10-301378080333
70ab6401f9-9310-40dd-8f15-0d7199e27925 (view SPL)Drug FactsotcHuman OTCSunmarkmanufacture2012-08-161493480924
71abbb8d6b-0a99-4d04-97f1-9f76fb689b34 (view SPL)Kroger Co. Pain Relief 8 HR Drug FactsotcHuman OTCKroger2012-12-032301420217
72ac5b24a4-39a8-4c8a-b293-5f59966fb444 (view SPL)Acetaminophen Extended-Release Tablets, USPPain Reliever/Fever ReducerotcHuman OTCAmerican Health PackagingREPACK2014-09-171680840777
73aef4fb40-0c1f-442d-9291-d06b024ce4c8 (view SPL)American Sales Company Arthritis Pain Relief Drug FactsotcHuman OTCFoodhold U.S.A., Llc2015-05-202415200966
74af407852-5476-421d-a80a-d726c24b6391 (view SPL)Publix Super Markets, Inc. Arthritis Pain Relief Drug FactsotcHuman OTCPublix Super Markets, Inc2015-05-293560620544
75b1d78d9a-81d6-4f24-a076-f627f748cdab (view SPL)Cardinal Health Pain Relief 8HR Drug FactsotcHuman OTCCardinal Health, Inc.2015-04-082497810062
76b3c76014-8783-4025-b459-85e070094b04 (view SPL)American Sales Company Pain Relief Drug FactsotcHuman OTCFoodhold U.S.A., Llc2015-02-243415200217
77b57e5a38-ff6a-4e72-b5e3-3952d785f825 (view SPL)Drug FactsotcHuman OTCCvsMANUFACTURE2014-10-201597790340
78b5ddc01d-40dc-400a-8a58-1e3a97d15142 (view SPL)Drug FactsotcHuman OTCBest Choice (Valu Merchandisers Company)manufacture2013-01-301639410336
79b6248c8f-d2de-4330-8ae7-1ee46bd0a19a (view SPL)Amerisource Bergen Arthritis Pain Relief Drug FactsotcHuman OTCGood Neighbor Pharmacy2015-05-293243850629
80b8373c83-6e2a-4dec-a242-e442b9653ff5 (view SPL)Drug FactsotcHuman OTCMckesson (Health Mart)manufacture2012-08-131620110026
81baac3c00-a651-4fd8-92f8-d790f1d0b1b7 (view SPL)Wal-Mart Arthritis Pain Drug FactsotcHuman OTCWalmart2015-03-055490350544
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83bba0b6cd-4573-4625-94d3-c02dadc9cf44 (view SPL)Walgreen Co. Pain Reliever Drug FactsotcHuman OTCWalgreens2011-11-151003630217
84bcaa4b41-6ad4-49c2-b5d3-b8e9653a6da6 (view SPL)Kmart Corporation Pain Relief 8 Hour Drug FactsotcHuman OTCKmart Corp2014-03-283497380217
85bfaa0ee9-37be-431f-a19d-2a4f3f7b3108 (view SPL)Drug FactsotcHuman OTCFoodhold U.S.A., Llcmanufacture2013-01-171415200333
86c0c4d567-4d3a-4eef-bd90-6e5b01f256ea (view SPL)BJWC Acetaminophen Drug FactsotcHuman OTCBjwc2012-07-162683910544
87c0f4d7f1-aa17-4233-bc47-41c280fdd7ce (view SPL)Drug FactsotcHuman OTCAmerisource Bergenmanufacture2012-10-251461220062
88c21f0f3f-fb2c-43d1-80d0-3a80a157c792 (view SPL)Costco Wholesale Corp. Arthritis Pain Drug FactsotcHuman OTCCostco Wholesale Company2015-08-043639810544
89c388f3a5-03bb-4fed-b81a-bb876bc260f0 (view SPL)Meijer Distribution, Inc. Arthritis Pain Relief Drug FactsotcHuman OTCMeijer Distribution, Inc2015-03-053412500966
90c5865a69-4fe4-4f0d-9e03-5927dd737445 (view SPL)American Sales Company Arthritis Pain Relief Drug FactsotcHuman OTCFoodhold U.S.A., Llc2015-05-204415200544
91c65ef88a-ec37-4d61-8420-17f4807ac93a (view SPL)Drug FactsotcHuman OTCFamily Dollar (Family Wellness)manufacture2012-09-191553190333
92c7c67069-df0e-41e8-b792-d277559bd40e (view SPL)Topco Associates LLC. Arthritis Pain Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2015-08-145368000544
93ca7217be-6927-4752-bc18-0fb423fb591c (view SPL)Dolgencorp, LLC Pain Reliever Drug FactsotcHuman OTCDolgencorp, Llc2013-01-292559100217
94d8259f15-ef0f-41bf-a038-0be4eacb2d79 (view SPL)Drug FactsotcHuman OTCFoodhold U.S.A., Llcmanufacture2013-01-171415200336
95d8fc6698-8d66-4ce9-bd29-0abbe111e8be (view SPL)Target Corporation Temporary, Minor Arthritis Pain Relief Drug FactsotcHuman OTCTarget Corp2013-02-263116730544
96da0e73c5-9d27-4343-8c28-9ff31e4b360e (view SPL)Hy-Vee, Inc. Arthritis Pain Relief Drug FactsotcHuman OTCHy-Vee2015-10-283425070966
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101e0aa4c5d-88c0-4484-9185-f33888421dd3 (view SPL)Drug FactsotcHuman OTCCvsmanufacture2014-02-141597790340
102e12098ad-8af1-45f3-817a-62dda19a9449 (view SPL)Drug FactsotcHuman OTCChain Drug Consortium, LlcMANUFACTURE2015-10-052680160340
103e2a34e69-30f9-4739-ad03-16d0c584a5e5 (view SPL)Wal-Mart Arthritis Pain Drug FactsotcHuman OTCWalmart2015-03-273490350407
104e2bb2925-4fc7-4597-8d0c-768a48d8e4f1 (view SPL)Rite Aid Corporation Acetaminophen Drug FactsotcHuman OTCRite Aid2015-02-172118220544
105f11519c4-9906-4826-8b98-b05b408369bc (view SPL)Dolgencorp, LLC Arthritis Pain Relief Drug FactsotcHuman OTCDolgencorp, Llc2015-05-293559100544
106f70fcaa4-da00-47d3-872c-d6220090c02d (view SPL)Cardinal Health Arthritis Pain Drug FactsotcHuman OTCCardinal Health, Inc.2015-03-052497810063
107fb307bc5-cb8b-49ea-878e-980ac5707436 (view SPL)HEB Pain Relief 8 HR Drug FactsotcHuman OTCH-E-B2015-02-242378080455
108fd5db3a6-efa2-4e8a-9783-a7b6e6701c58 (view SPL)Dolgencorp, LLC Pain Relief Drug FactsotcHuman OTCDolgencorp, Llc2015-08-171559100435
109fd658f54-4efd-4b40-877b-f51eb6abcfe3 (view SPL)Safeway Inc. Pain Relief Drug FactsotcHuman OTCBetter Living Brands Llc2010-11-221211300217
110fe4e9ec5-fa9c-4494-8516-ab477e0fa918 (view SPL)Drug FactsotcHuman OTCQuality Choice (Chain Drug Marketing Association)manufacture2012-10-031638680089

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII