Ibuprofen Chewable Tablet

Brand(s)
Advil
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Pfizer Consumer Healthcare (2013-12-23)
Oldest Current Product
1990-11-15
License(s)
NDA, ANDA
RxNORM
CHEWABLE TABLET\IBUPROFEN
FDAOB
ORAL\TABLET, CHEWABLE\IBUPROFEN
SPL Active
ORAL\TABLET, CHEWABLE\IBUPROFEN
SPL Moiety
ORAL\TABLET, CHEWABLE\IBUPROFEN

product(s) by strength(s)

ibuprofen 100 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005730179AdvilNDAPfizer Consumer Healthcare2011-06-01IBUPROFENORALTABLET, CHEWABLENDA02094407d4c400-b182-92f7-7574-9e0e94c39cce

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130461ANDAL. Perrigo Company2004-11-09IBUPROFENORALTABLET, CHEWABLEANDA07635967e15204-4f36-434d-8b2d-4889d7608204
2003630507ANDAWalgreens2013-12-09IBUPROFENORALTABLET, CHEWABLEANDA076359695e2435-fea1-4889-a3e8-a71c7dc5688c
3003630521ANDAWalgreens2009-05-05IBUPROFENORALTABLET, CHEWABLEANDA07635905774c2c-825a-4538-aad2-8416b63d0e06
4003630523ANDAWalgreens2012-12-18IBUPROFENORALTABLET, CHEWABLEANDA07635932eb1ff1-07ec-441d-9d1a-a6c05ced4427
5116730461ANDATarget Corp2013-03-04IBUPROFENORALTABLET, CHEWABLEANDA076359c6347c86-9ce1-46ca-9631-7ef9c0ae8913
6116730521ANDATarget Corp2010-06-22IBUPROFENORALTABLET, CHEWABLEANDA0763596acd5878-35b6-452a-b00b-a69467a7c8f2
7118220010ANDARite Aid2004-05-06IBUPROFENORALTABLET, CHEWABLEANDA0763599b3fd2ee-210c-4a51-9310-1dba110ce4fe
8118220521ANDARite Aid2010-06-25IBUPROFENORALTABLET, CHEWABLEANDA076359446f952b-ad82-43ee-bad3-0a182fa49de5
9211300026ANDABetter Living Brands Llc2015-09-29IBUPROFENORALTABLET, CHEWABLEANDA0763594346814f-4139-4081-9734-4385030907ba
10243850546ANDAGood Neighbor Pharmacy2004-10-12IBUPROFENORALTABLET, CHEWABLEANDA076359c02a347d-df05-4191-b506-1b2ad754a014
11301420461ANDAKroger2004-05-10IBUPROFENORALTABLET, CHEWABLEANDA0763595107e0cd-8df6-40b0-9171-dd88370e4337
12368000461ANDATop Care (Topco Associates Llc)2004-05-28IBUPROFENORALTABLET, CHEWABLEANDA076359a038b1b0-278e-4b5f-b949-f4233e98f3cf
13370120461ANDAShopko Stores Operating Co, Llc2013-07-30IBUPROFENORALTABLET, CHEWABLEANDA07635940097d6e-588f-42db-a4f5-77f7d9692414
14370120521ANDAShopko Stores Operating Co, Llc2013-08-06IBUPROFENORALTABLET, CHEWABLEANDA076359fd3db5ab-f9ac-4a16-a550-27ab99854690
15372050402ANDACardinal Health2004-05-28IBUPROFENORALTABLET, CHEWABLEANDA076359019f2ddb-29cd-41b9-b7dd-7a96569febbf
16372050852ANDACardinal Health1990-11-15IBUPROFENORALTABLET, CHEWABLEANDA076359ce54a65b-2913-450f-b7af-b23c54fbb742
17378080251ANDAH-E-B2010-09-01IBUPROFENORALTABLET, CHEWABLEANDA076359a3ea52f0-8774-41fd-93ed-0c54e357c6d2
18411630521ANDASupervalu, Inc2011-05-04IBUPROFENORALTABLET, CHEWABLEANDA076359e3aac5f2-5626-48c9-aad3-d8bccf893d14
19411900461ANDAWakefern Food Corporation2013-07-02IBUPROFENORALTABLET, CHEWABLEANDA0763599aac3058-931d-4559-bf62-4363c91ee707
20412500461ANDAMeijer Distribution, Inc2004-05-02IBUPROFENORALTABLET, CHEWABLEANDA07635975c820b8-88ce-41e0-ab2f-eb7f3b19bc04
21412680461ANDAHannaford Brothers Company2004-06-24IBUPROFENORALTABLET, CHEWABLEANDA076359dde25179-091d-47f5-9de6-909861528e55
22415200461ANDAFoodhold U.S.A., Llc2004-09-13IBUPROFENORALTABLET, CHEWABLEANDA0763590880a03d-53f6-4e1b-842c-002b2c01ccc3
23415200600ANDAFoodhold U.S.A., Llc2010-05-21IBUPROFENORALTABLET, CHEWABLEANDA076359368e6d1b-8521-4ca6-9151-e69ea7660b04
24425070461ANDAHy-Vee2005-02-12IBUPROFENORALTABLET, CHEWABLEANDA0763592fd51545-1d1f-4b2e-a084-d28ba223e720
25490350521ANDAWalmart2011-10-25IBUPROFENORALTABLET, CHEWABLEANDA076359abef43bc-ee9b-4a9c-9cf9-36c323213909
26493480639ANDASunmark2004-07-10IBUPROFENORALTABLET, CHEWABLEANDA076359107a79ca-1917-48d2-9e7d-b87ab4bade17
27497380461ANDAKmart Corp2010-06-24IBUPROFENORALTABLET, CHEWABLEANDA0763598df4cdb7-5eb3-4fff-9eda-98ff24197af6
28553120461ANDAWestern Family2004-09-24IBUPROFENORALTABLET, CHEWABLEANDA076359734289dc-b048-4386-880f-45dc09147ce0
29553120521ANDAWestern Family2009-04-07IBUPROFENORALTABLET, CHEWABLEANDA076359413d4788-a215-43bb-991b-77dc6d69d253
30553160461ANDADza Brands,2011-06-30IBUPROFENORALTABLET, CHEWABLEANDA0763590437821b-79e6-4bdc-950b-898f1ce5b0d8
31559100521ANDADolgencorp, Llc2010-09-14IBUPROFENORALTABLET, CHEWABLEANDA076359869185d5-9f34-4d38-9551-dd0b4fc8557d
32560620461ANDAPublix Super Markets, Inc2004-10-28IBUPROFENORALTABLET, CHEWABLEANDA076359710aba07-3a81-47ab-89fb-3b4427468960
33597790001ANDACvs2004-05-07IBUPROFENORALTABLET, CHEWABLEANDA076359d9ee76c1-4370-4c0f-98e0-e232795ccf73
34597790521ANDACvs1991-11-05IBUPROFENORALTABLET, CHEWABLEANDA076359d3b132ad-5794-4aea-bb20-6e6a9195c6b2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685623ANDAPhysicians Total Care, Inc.2007-10-16IBUPROFENORALTABLET, CHEWABLE243850546ANDA0763594de8b851-adce-443e-a3a1-62a887b8dd96
2682582994ANDADispensing Solutions, Inc.2004-11-09IBUPROFENORALTABLET, CHEWABLE001130461ANDA07635956cb55bf-3fd8-4613-bc45-73e53204dc97

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA076359IBUPROFENL PERRIGO CO2004-01-16ANDA076359_001, ANDA076359_002Ibuprofen Oral Tablet
2NDA020135MOTRINTrueMCNEIL PEDIATRICS1994-11-16NDA020135_001, NDA020135_002Ibuprofen Oral Tablet
3NDA020601CHILDREN'S MOTRINJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1996-11-15NDA020601_001, NDA020601_003Ibuprofen Oral Tablet
4NDA020944CHILDREN'S ADVILPFIZER INC1998-12-18NDA020944_001, NDA020944_002Ibuprofen Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA076359_001OTCIBUPROFEN (50MG)ORALTABLET, CHEWABLEFalse2004-01-16IBUPROFEN
2ANDA076359_002OTCIBUPROFEN (100MG)ORALTABLET, CHEWABLEFalse2004-01-16IBUPROFEN
3NDA020135_001discontinuedIBUPROFEN (50MG)ORALTABLET, CHEWABLEFalse1994-11-16MOTRIN
4NDA020135_002discontinuedIBUPROFEN (100MG)ORALTABLET, CHEWABLEFalse1994-11-16MOTRIN
5NDA020601_001OTCIBUPROFEN (50MG)ORALTABLET, CHEWABLEFalse1996-11-15CHILDREN'S MOTRIN
6NDA020601_003OTCIBUPROFEN (100MG)ORALTABLET, CHEWABLETrue1996-11-15CHILDREN'S MOTRIN
7NDA020944_001OTCIBUPROFEN (50MG)ORALTABLET, CHEWABLEFalse1998-12-18CHILDREN'S ADVIL
8NDA020944_002OTCIBUPROFEN (100MG)ORALTABLET, CHEWABLEFalse1998-12-18CHILDREN'S ADVIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1019f2ddb-29cd-41b9-b7dd-7a96569febbf (view SPL)Cardinal Health Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCCardinal Health2011-12-071372050402
20437821b-79e6-4bdc-950b-898f1ce5b0d8 (view SPL)DZA Brands, LLC Ibuprofen Tablets 100mg Drug FactsotcHuman OTCDza Brands,2011-12-071553160461
305774c2c-825a-4538-aad2-8416b63d0e06 (view SPL)Walgreen Co. Ibuprofen Drug FactsotcHuman OTCWalgreens2011-09-283003630521
407d4c400-b182-92f7-7574-9e0e94c39cce (view SPL)Junior Strength Advil (Ibuprofen) ChewablesotcHuman OTCPfizer Consumer HealthcareANALYSIS, LABEL, MANUFACTURE, PACK2013-12-232005730179
50880a03d-53f6-4e1b-842c-002b2c01ccc3 (view SPL)American Sales Company Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCFoodhold U.S.A., Llc2009-07-011415200461
6107a79ca-1917-48d2-9e7d-b87ab4bade17 (view SPL)McKesson Ibuprofen IB Drug FactsotcHuman OTCSunmark2011-12-071493480639
72fd51545-1d1f-4b2e-a084-d28ba223e720 (view SPL)Hy-Vee, Inc. Junior Strength Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCHy-Vee2011-09-261425070461
832eb1ff1-07ec-441d-9d1a-a6c05ced4427 (view SPL)Walgreen Co. Ibuprofen 100 Junior Strength Drug FactsotcHuman OTCWalgreens2013-07-012003630523
9368e6d1b-8521-4ca6-9151-e69ea7660b04 (view SPL)American Sales Company Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCFoodhold U.S.A., Llc2014-08-061415200600
1040097d6e-588f-42db-a4f5-77f7d9692414 (view SPL)Shopko Junior Strength Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCShopko Stores Operating Co, Llc2013-09-051370120461
11413d4788-a215-43bb-991b-77dc6d69d253 (view SPL)Western Family Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCWestern Family2009-06-051553120521
124346814f-4139-4081-9734-4385030907ba (view SPL)Better Living Brands LLC Ibuprofen Drug FactsotcHuman OTCBetter Living Brands Llc2015-09-301211300026
13446f952b-ad82-43ee-bad3-0a182fa49de5 (view SPL)Rite Aid Corporation Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCRite Aid2013-09-202118220521
144de8b851-adce-443e-a3a1-62a887b8dd96 (view SPL)Amerisource Bergen Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCPhysicians Total Care, Inc.relabel2012-05-021548685623
155107e0cd-8df6-40b0-9171-dd88370e4337 (view SPL)Kroger Co. Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCKroger2014-06-262301420461
1656cb55bf-3fd8-4613-bc45-73e53204dc97 (view SPL)Perrigo Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCDispensing Solutions, Inc.relabel, repack2013-11-061682582994
1767e15204-4f36-434d-8b2d-4889d7608204 (view SPL)Perrigo Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCL. Perrigo Company2011-09-261001130461
18695e2435-fea1-4889-a3e8-a71c7dc5688c (view SPL)Walgreen Co. Ibuprofen 100 Drug FactsotcHuman OTCWalgreens2014-01-071003630507
196acd5878-35b6-452a-b00b-a69467a7c8f2 (view SPL)Target Corporation Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCTarget Corp2015-03-092116730521
20710aba07-3a81-47ab-89fb-3b4427468960 (view SPL)Publix Super Markets, Inc. Ibuprofen Tablets Drug FactsotcHuman OTCPublix Super Markets, Inc2011-12-211560620461
21734289dc-b048-4386-880f-45dc09147ce0 (view SPL)Western Family Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCWestern Family2011-09-261553120461
2275c820b8-88ce-41e0-ab2f-eb7f3b19bc04 (view SPL)Meijer Distribution, Inc. Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCMeijer Distribution, Inc2009-07-011412500461
23869185d5-9f34-4d38-9551-dd0b4fc8557d (view SPL)Dolgencorp, LLC Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCDolgencorp, Llc2010-09-141559100521
248df4cdb7-5eb3-4fff-9eda-98ff24197af6 (view SPL)Kmart Corporation Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCKmart Corp2011-09-261497380461
259aac3058-931d-4559-bf62-4363c91ee707 (view SPL)ShopRite Ibuprofen IB Drug FactsotcHuman OTCWakefern Food Corporation2013-09-121411900461
269b3fd2ee-210c-4a51-9310-1dba110ce4fe (view SPL)Rite Aid Corporation Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCRite Aid2014-02-202118220010
27a038b1b0-278e-4b5f-b949-f4233e98f3cf (view SPL)Topco Associates LLC. Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2011-12-072368000461
28a3ea52f0-8774-41fd-93ed-0c54e357c6d2 (view SPL)HEB Junior Strength Ibuprofen Drug FactsotcHuman OTCH-E-B2010-09-011378080251
29abef43bc-ee9b-4a9c-9cf9-36c323213909 (view SPL)Wal-Mart Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCWalmart2015-06-033490350521
30c02a347d-df05-4191-b506-1b2ad754a014 (view SPL)Amerisource Bergen Junior Strength Ibuprofen Tablets, 100 mg Drug FactsotcHuman OTCGood Neighbor Pharmacy2011-09-261243850546
31c6347c86-9ce1-46ca-9631-7ef9c0ae8913 (view SPL)Target Corporation Junior Strength Ibuprofen Tablets Drug FactsotcHuman OTCTarget Corp2015-01-272116730461
32ce54a65b-2913-450f-b7af-b23c54fbb742 (view SPL)Cardinal Health Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCCardinal Health2009-06-051372050852
33d3b132ad-5794-4aea-bb20-6e6a9195c6b2 (view SPL)CVS Pharmacy, Inc. Ibuprofen Drug FactsotcHuman OTCCvs2015-10-193597790521
34d9ee76c1-4370-4c0f-98e0-e232795ccf73 (view SPL)CVS Pharmacy, Inc. Junior Strength Ibuprofen Tablets Drug FactsotcHuman OTCCvs2015-10-164597790001
35dde25179-091d-47f5-9de6-909861528e55 (view SPL)Hannaford Bros. Co. Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCHannaford Brothers Company2009-07-011412680461
36e3aac5f2-5626-48c9-aad3-d8bccf893d14 (view SPL)SuperValu Inc. Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCSupervalu, Inc2014-12-042411630521
37fd3db5ab-f9ac-4a16-a550-27ab99854690 (view SPL)Shopko Junior Strength Ibuprofen Tablets 100 mg Drug FactsotcHuman OTCShopko Stores Operating Co, Llc2013-09-051370120521

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