Guaifenesin Extended Release Oral Tablet

Brand(s)
Mucinex
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Preferred Plus (Kinray) (2015-10-05)
Oldest Current Product
2003-03-05
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\GUAIFENESIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\GUAIFENESIN
SPL Active
ORAL\TABLET, EXTENDED RELEASE\GUAIFENESIN
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\GUAIFENESIN

product(s) by strength(s)

12 hr guaifenesin 1200 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1638240023MucinexNDAReckitt Benckiser Llc2012-06-26GUAIFENESINORALTABLET, EXTENDED RELEASENDA02128247f5323c-ee3a-400d-b133-31d9c286fafd

12 hr guaifenesin 600 mg extended release oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1497810035Cardinal Health, Inc.GUAIFENESINORALTABLET, EXTENDED RELEASEe4912fdd-f771-49ab-b6eb-9df8571dc7ab
2597790498CvsGUAIFENESINORALTABLET, EXTENDED RELEASEf78d52c3-4139-4a63-b222-5f4dea1d2b4f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130498ANDAL. Perrigo Company2013-03-21GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789126e7e17a3-7af4-430e-98e0-00af0d017e13
2003630498ANDAWalgreens2013-03-18GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912b73ec512-aba6-4962-866f-672e3f61a266
3005361026ANDARugby Laboratories2014-10-27GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912c18413a1-c61d-46d1-bb29-1422c09c015f
4009046133ANDAMajor2013-03-20GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891236e1d697-daf6-43be-883d-57422eb07eab
5102020498ANDA7-Eleven2014-10-26GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891246949861-f48b-47ae-acad-9ac8c97ea77d
6118220498ANDARite Aid2013-03-20GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789124826aad7-1450-4145-932c-e5602e76eb01
7211300038ANDABetter Living Brands Llc2015-08-19GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912f8afa303-31c8-483d-b296-c08825b46107
8211300498ANDABetter Living Brands Llc2013-07-25GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912341f6c0d-fe4a-4732-9082-7f4268c89389
9211300500ANDABetter Living Brands Llc2013-07-25GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891255e8f5a5-c21d-4e73-a549-64fea1eb7c0d
10301420498ANDAKroger2013-03-18GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789127bae5428-2577-4465-8deb-0f889f67c669
11368000498ANDATop Care (Topco Associates Llc)2013-03-18GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912f6e1c1cb-a287-4dd2-a047-8b4ac4c0d6a4
12370120498ANDAShopko Stores Operating Co, Llc2013-07-08GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912bbc88946-23dd-4cad-92da-f7c6f9036171
13372050628ANDACardinal Health2013-03-19GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912f35445bd-138e-4aa3-bd00-df6224d46e5b
14378080498ANDAH-E-B2013-03-19GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912ad3a71b8-9124-42f8-a25d-cadbb675d721
15411630498ANDASupervalu, Inc2013-08-06GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891295057e07-1735-4910-a220-5b2afa34fd8c
16411900498ANDAWakefern Food Corporation2013-08-26GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891211026777-ac62-4aee-ba7f-07cfd6b40a00
17412500498ANDAMeijer Distribution, Inc2013-03-18GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912ec97cee3-54c2-4f1d-8fd1-fbe14487592f
18415200498ANDAFoodhold U.S.A., Llc2013-04-21GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789123444cf52-7ca7-44b5-bdac-2c352249e674
19425070498ANDAHy-Vee2013-03-18GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789121a375cf0-965a-4a77-b40a-1e2f322e96c6
20458020498ANDAPerrigo New York Inc2012-03-28GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789129f22e1c5-01ac-447c-b9dd-bb29e72d75c8
21461220028ANDAAmerisource Bergen2013-03-19GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789123aa8a59f-06dd-4f1f-85af-da7eaef6883d
22490350498ANDAWalmart2013-03-22GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912530bf556-4ab6-4361-817d-5de3b47e6c97
23493480905ANDASunmark2013-03-18GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912070442e0-4b1c-48c1-bc11-b4e04878b7a8
24497380035ANDAKmart Corp2015-08-20GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912a55cd9b9-8828-4aee-94ae-ec45ec877970
25497380498ANDAKmart Corp2013-08-05GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912070f0538-e105-4211-8aa2-a67a403cde30
26505940009ANDABig Lots2015-04-28GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891200b28f45-5d6c-4ba3-8f5a-c55c0db5d133
27553120498ANDAWestern Family2013-03-25GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789124ff8297e-297e-4fe3-96da-61e7e2da2e2c
28553160498ANDADza Brands,2014-10-30GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912c05f1a8d-de83-42d1-9af5-4f3e1e3f80a6
29559100310ANDADolgencorp, Llc2015-07-23GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912132a75d8-d66f-4e61-b240-a5c94f2ea5af
30559100498ANDADolgencorp, Llc2013-05-17GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912fe87b312-d8dc-4138-aecc-e3918eb10731
31560620498ANDAPublix Super Markets, Inc2013-03-25GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912bf6755e7-e9b5-442c-8db0-bfe8eff3dc12
32578960797ANDAGericare Pharmaceuticals2015-01-08GUAIFENESINORALTABLET, EXTENDED RELEASEANDA07891268cd5e3d-32ea-4b5d-8177-8acb44b5aac8
33617150125ANDAPreferred Plus (Kinray)2014-10-13GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789126a36c9a6-5e22-40f7-bf58-b34be68ac9d6
34620110076ANDAMckesson (Health Mart)2013-03-19GUAIFENESINORALTABLET, EXTENDED RELEASEANDA078912b62f5ba8-6521-4a83-925e-fe24da722001
35681960498ANDASam'S West, Inc2013-08-20GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789125ee1d65e-d617-4b6f-b17d-a7323ba83498
36683910498ANDABjwc2014-11-07GUAIFENESINORALTABLET, EXTENDED RELEASEANDA0789128f07cd17-1898-4f03-8b82-a31fe8ec04bc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157712ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-03-28GUAIFENESINORALTABLET, EXTENDED RELEASE458020498ANDA078912f3f7802e-ee96-4462-a7e6-bb087d0fdcf5
2178560008MucinexNDAAtlantic Biologicals Corps2012-07-03GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA02128240c67cca-f202-4652-9507-2442d26cfd67
3216950870MucinexNDARebel Distributors Corp2009-03-27GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA021282e4ac51f1-9b5e-49ad-ac79-dde6e91b65e9
4538080871MucinexNDAState Of Florida Doh Central Pharmacy2013-01-01GUAIFENESINORALTABLET, EXTENDED RELEASE551547776NDA021282594ad1e6-4221-4a4a-89db-a214ddf8306e
5548684750MucinexNDAPhysicians Total Care, Inc.2003-03-05GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA0212821fee6f84-bae6-460e-8ca9-d746851dff5d
6550453143MucinexNDADispensing Solutions, Inc.2010-05-12GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA0212826c53cc58-aaab-49f5-8d61-7ce2681bc6a8
7551547776MucinexNDACardinal Health2009-03-27GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA0212825deaa86e-993d-4af9-9494-5a0de95e8291
8551547777MucinexNDACardinal Health2010-07-22GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA0212828ebc5b8c-a578-4f73-b5a1-3ea18a6b646e
9619190651NDADirect Rx2014-01-01GUAIFENESINORALTABLET, EXTENDED RELEASE638240008NDA021282615ac5b7-426c-4bfb-9826-87735c6288cb

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA078912GUAIFENESINPERRIGO R AND D CO2011-11-23ANDA078912_001
2ANDA091009GUAIFENESINACTAVIS LABORATORIES FL INC2015-09-03ANDA091009_002
3NDA021282MUCINEXRECKITT BENCKISER LLC2002-07-12p6372252, EXPECTORANT
p6955821, EXPECTORANT, SUBSTANCE
p7838032, SUBSTANCE
NDA021282_001, NDA021282_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA078912_001OTCGUAIFENESIN (600MG)ORALTABLET, EXTENDED RELEASEFalse2011-11-23GUAIFENESIN
2ANDA091009_002OTCGUAIFENESIN (1.2GM)ORALTABLET, EXTENDED RELEASEFalse2015-09-03GUAIFENESIN
3NDA021282_001OTCGUAIFENESIN (600MG)ORALTABLET, EXTENDED RELEASEFalse2002-07-12MUCINEX
4NDA021282_002OTCGUAIFENESIN (1.2GM)ORALTABLET, EXTENDED RELEASETrue2002-12-18MUCINEX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6372252 (view patent)2020-04-28NDA021282, NDA021585, NDA021620Dextromethorphan / Guaifenesin Extended Release Oral Tablet
Guaifenesin / Pseudoephedrine Extended Release Oral Tablet
2p6955821 (view patent)2020-04-28NDA021282, NDA021585, NDA021620Dextromethorphan / Guaifenesin Extended Release Oral Tablet
Guaifenesin / Pseudoephedrine Extended Release Oral Tablet
3p7838032 (view patent)2020-04-28NDA021282, NDA021585, NDA021620Dextromethorphan / Guaifenesin Extended Release Oral Tablet
Guaifenesin / Pseudoephedrine Extended Release Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100b28f45-5d6c-4ba3-8f5a-c55c0db5d133 (view SPL)Big Lots, Inc Mucus Relief Drug FactsotcHuman OTCBig Lots2015-05-041505940009
2070442e0-4b1c-48c1-bc11-b4e04878b7a8 (view SPL)McKesson MucusER Drug FactsotcHuman OTCSunmark2014-05-302493480905
3070f0538-e105-4211-8aa2-a67a403cde30 (view SPL)Kmart Corporation Mucus ER Drug FactsotcHuman OTCKmart Corp2014-05-052497380498
411026777-ac62-4aee-ba7f-07cfd6b40a00 (view SPL)ShopRite Mucus Relief Drug FactsotcHuman OTCWakefern Food Corporation2013-10-011411900498
5132a75d8-d66f-4e61-b240-a5c94f2ea5af (view SPL)Dolgencorp, LLC Mucus ER Drug FactsotcHuman OTCDolgencorp, Llc2015-07-231559100310
61a375cf0-965a-4a77-b40a-1e2f322e96c6 (view SPL)Hy-Vee, Inc. MucusER Drug FactsotcHuman OTCHy-Vee2015-06-292425070498
71fee6f84-bae6-460e-8ca9-d746851dff5d (view SPL)MucinexotcHuman OTCPhysicians Total Care, Inc.relabel2009-12-181548684750
8341f6c0d-fe4a-4732-9082-7f4268c89389 (view SPL)Safeway Inc. Mucus ER Drug FactsotcHuman OTCBetter Living Brands Llc2013-09-241211300498
93444cf52-7ca7-44b5-bdac-2c352249e674 (view SPL)American Sales Company Mucus ER Drug FactsotcHuman OTCFoodhold U.S.A., Llc2014-05-052415200498
1036e1d697-daf6-43be-883d-57422eb07eab (view SPL)Major Pharmaceuticals Mucus ER Drug FactsotcHuman OTCMajor2013-03-251009046133
113aa8a59f-06dd-4f1f-85af-da7eaef6883d (view SPL)Amerisource Bergen MucusER Drug FactsotcHuman OTCAmerisource Bergen2014-10-313461220028
1240c67cca-f202-4652-9507-2442d26cfd67 (view SPL)Mucinex otcHuman OTCAtlantic Biologicals CorpsREPACK2012-07-203178560008
1346949861-f48b-47ae-acad-9ac8c97ea77d (view SPL)7-Eleven Mucus Relief Drug FactsotcHuman OTC7-Eleven2014-10-271102020498
1447f5323c-ee3a-400d-b133-31d9c286fafd (view SPL)MAXIMUM STRENGTH Mucinex EXPECTORANTotcHuman OTCReckitt Benckiser Llc2015-06-088638240023
154826aad7-1450-4145-932c-e5602e76eb01 (view SPL)Rite Aid Corporation Mucus Relief Drug FactsotcHuman OTCRite Aid2013-10-302118220498
164ff8297e-297e-4fe3-96da-61e7e2da2e2c (view SPL)Western Family Expectorant Guaifenesin Extended-Release Tablets, 600 mg Drug FactsotcHuman OTCWestern Family2013-07-301553120498
17530bf556-4ab6-4361-817d-5de3b47e6c97 (view SPL)Wal-Mart Mucus ER Drug FactsotcHuman OTCWalmart2014-05-042490350498
1855e8f5a5-c21d-4e73-a549-64fea1eb7c0d (view SPL)Safeway Inc. Mucus Relief Drug FactsotcHuman OTCBetter Living Brands Llc2014-04-091211300500
19594ad1e6-4221-4a4a-89db-a214ddf8306e (view SPL)MucinexotcHuman OTCState Of Florida Doh Central Pharmacyrepack2013-09-261538080871
205deaa86e-993d-4af9-9494-5a0de95e8291 (view SPL)MucinexotcHuman OTCCardinal HealthREPACK2011-06-011551547776
215ee1d65e-d617-4b6f-b17d-a7323ba83498 (view SPL)Sams West, Inc. Mucus Relief Drug FactsotcHuman OTCSam'S West, Inc2014-05-042681960498
22615ac5b7-426c-4bfb-9826-87735c6288cb (view SPL)MUCINEXotcHuman OTCDirect Rxrelabel, repack2015-03-132619190651
2368cd5e3d-32ea-4b5d-8177-8acb44b5aac8 (view SPL)Gericare Pharmaceuticals MucusER Drug FactsotcHuman OTCGericare Pharmaceuticals2015-02-161578960797
246a36c9a6-5e22-40f7-bf58-b34be68ac9d6 (view SPL)Kinray, LLC Mucus ER Drug FactsotcHuman OTCPreferred Plus (Kinray)2015-10-052617150125
256c53cc58-aaab-49f5-8d61-7ce2681bc6a8 (view SPL)MucinexotcHuman OTCDispensing Solutions, Inc.relabel, repack2011-06-291550453143
266e7e17a3-7af4-430e-98e0-00af0d017e13 (view SPL)Perrigo MucusER Drug FactsotcHuman OTCL. Perrigo Company2014-05-052001130498
277240cc18-c8d0-48d7-925a-56bfd2a55691 (view SPL)Target Corporation Mucus Relief Drug FactsotcHuman OTCTarget Corp2015-07-083116730498
287bae5428-2577-4465-8deb-0f889f67c669 (view SPL)Kroger Co. Mucus-ER Drug FactsotcHuman OTCKroger2014-09-264301420498
298ebc5b8c-a578-4f73-b5a1-3ea18a6b646e (view SPL)MucinexotcHuman OTCCardinal HealthREPACK2015-04-096551547777
308f07cd17-1898-4f03-8b82-a31fe8ec04bc (view SPL)BJWC Mucus Relief Drug FactsotcHuman OTCBjwc2015-04-132683910498
3195057e07-1735-4910-a220-5b2afa34fd8c (view SPL)SuperValu Inc. Mucus ER Drug FactsotcHuman OTCSupervalu, Inc2015-01-283411630498
329f22e1c5-01ac-447c-b9dd-bb29e72d75c8 (view SPL)Perrigo Guaifenesin Extended-Release Tablets Drug FactsotcHuman OTCPerrigo New York Inc2013-03-222458020498
33a55cd9b9-8828-4aee-94ae-ec45ec877970 (view SPL)Kmart Corporation Chest Congestion Drug FactsotcHuman OTCKmart Corp2015-08-201497380035
34ad3a71b8-9124-42f8-a25d-cadbb675d721 (view SPL)HEB Mucus Relief Drug FactsotcHuman OTCH-E-B2013-04-041378080498
35b62f5ba8-6521-4a83-925e-fe24da722001 (view SPL)McKesson Mucus ER Drug FactsotcHuman OTCMckesson (Health Mart)2014-05-272620110076
36b73ec512-aba6-4962-866f-672e3f61a266 (view SPL)Walgreen Co. Mucus Relief ER Drug FactsotcHuman OTCWalgreens2014-05-302003630498
37bbc88946-23dd-4cad-92da-f7c6f9036171 (view SPL)Shopko Mucus ER Drug FactsotcHuman OTCShopko Stores Operating Co, Llc2014-05-052370120498
38bf6755e7-e9b5-442c-8db0-bfe8eff3dc12 (view SPL)Publix Super Markets, Inc. Mucus ER Drug FactsotcHuman OTCPublix Super Markets, Inc2014-05-052560620498
39c05f1a8d-de83-42d1-9af5-4f3e1e3f80a6 (view SPL)DZA Brands, LLC Mucus Relief Drug FactsotcHuman OTCDza Brands,2015-06-252553160498
40c18413a1-c61d-46d1-bb29-1422c09c015f (view SPL)Rugby Laboratories MucusER Drug FactsotcHuman OTCRugby Laboratories2014-11-041005361026
41dd379cdd-90ab-42e0-ad89-f50d3220f611 (view SPL)MucinexotcHuman OTCReckitt Benckiser Llc2014-09-059638240008
42e4912fdd-f771-49ab-b6eb-9df8571dc7ab (view SPL)Cardinal Health MucusER Drug FactsotcHuman OTCCardinal Health, Inc.2015-09-231497810035
43e4ac51f1-9b5e-49ad-ac79-dde6e91b65e9 (view SPL)MucinexotcHuman OTCRebel Distributors CorpRELABEL, REPACK2011-04-132216950870
44ec97cee3-54c2-4f1d-8fd1-fbe14487592f (view SPL)Meijer Distribution, Inc. Mucus Relief Drug FactsotcHuman OTCMeijer Distribution, Inc2013-03-311412500498
45f35445bd-138e-4aa3-bd00-df6224d46e5b (view SPL)Cardinal Health MucusER Drug FactsotcHuman OTCCardinal Health2014-05-283372050628
46f3f7802e-ee96-4462-a7e6-bb087d0fdcf5 (view SPL)Guaifenesin ER TabsotcHuman OTCNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-07-061006157712
47f6e1c1cb-a287-4dd2-a047-8b4ac4c0d6a4 (view SPL)Topco Associates LLC. MucusER Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2014-05-043368000498
48f78d52c3-4139-4a63-b222-5f4dea1d2b4f (view SPL)CVS Pharmacy, Inc. Mucus Extended Release Drug FactsotcHuman OTCCvs2015-07-084597790498
49f8afa303-31c8-483d-b296-c08825b46107 (view SPL)Better Living Brands LLC Mucus Relief Drug FactsotcHuman OTCBetter Living Brands Llc2015-08-241211300038
50fe87b312-d8dc-4138-aecc-e3918eb10731 (view SPL)Dolgencorp, LLC Mucus Relief-ER Drug FactsotcHuman OTCDolgencorp, Llc2013-10-011559100498

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