FDA.reportPublic FDA data

Application 074937

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S IBUPROFENIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074937-001CHILDREN'S IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074937-001CHILDREN'S IBUPROFEN100MG/5MLSUSPENSION / ORAL1998-12-22f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENNuCare Pharmaceuticals,Inc.59554a62-3a9a-c0f3-e063-6294a90ad3fd2026-08-18WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC0865fe8a-df81-4ae4-8bed-29a022ba164f2026-08-17WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENRite Aid Corporation1da544eb-ed4e-4124-bea3-f827f13222702026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.52d3e633-13a2-cdcd-e063-6394a90ac1892026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENRite Aid Corporation69ca781a-202e-4579-91e6-f32a22ccc22c2026-05-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENWalgreen Companyf67612e8-38f3-4d1c-889b-57995a2f9f662026-05-15WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
care one ibuprofenIBUPROFENAmerican Sales Companyd26d2766-6d4c-462b-ae8b-ef8d87acd6332026-04-16WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Childrens IbuprofenIBUPROFENCardinal Health 107, LLC9291857c-30b3-414b-99e1-9c127e72c0d42026-04-16WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Ibuprofen childrensIBUPROFENHyVee Inc55f8def6-f7de-4b3e-a92a-5cd9e68a46a12026-04-15WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
CHILDRENS IbuprofenIBUPROFENKesin Pharma Corporation436c0126-4ff3-c082-e063-6294a90a3d722026-04-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofen childrensIBUPROFENHyVee Inc3d8497c6-1c46-4248-b75c-b086591529cc2026-04-10WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENCVS Pharmacyef204cc0-4009-4dd0-83e2-2b5ad6f984092026-02-27WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ndc (product): 59779-685
equate ibuprofen childrensIBUPROFENWal-Mart Stores Inc7817923f-4c21-4943-a7e2-dad4e2915fc42026-02-23WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
ibuprofenIBUPROFENHyVee Incc20a9bc5-e481-4fb2-ad10-d01e83e43ca02026-02-21WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
Ibuprofen ChildrensIBUPROFENMajor Pharmaceuticals9d56e64d-7860-4fd1-88d2-c537e50079d82026-02-13WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
childrens ibuprofenIBUPROFENHyVee Incd522a3ac-dd43-4faa-b3f8-69313be1c8292026-02-11WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937
IbuprofenIBUPROFENMajor Pharmaceuticals847758ed-66fc-4db9-8fdb-78f3c3291a032026-01-26WarningsExact identifier
application applno (ANDA): 074937
application number: ANDA074937

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 233 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55910-102dg health childrens ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-166DG Health childrens ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-166DG Health childrens ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-166DG Health childrens ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-685Rexall IbuprofenIbuprofenDolgencorp IncANDACurrent
55910-897DG Health IbuprofenIbuprofenDolgencorp IncANDACurrent
55910-897DG Health IbuprofenIbuprofenDolgencorp IncANDACurrent
56062-166profen ibIbuprofenPublix Super Markets IncANDACurrent
56062-897profen IBIbuprofenPublix Super Markets IncANDACurrent
59779-166IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-166IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-660ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-660ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-685IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-685IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-685IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-882Childrens IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-897ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-971Childrens IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-971Childrens IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-971Childrens IbuprofenIbuprofenCVS PharmacyANDACurrent
62011-0010health mart childrens ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0010health mart childrens ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0010health mart childrens ibuprofenIbuprofenMcKessonANDACurrent
62011-0011health mart ibuprofenIbuprofenMcKessonANDACurrent
62011-0011health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0011health mart ibuprofenIbuprofenMcKessonANDACurrent
62011-0011health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0030health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0030health mart ibuprofenIbuprofenMcKessonANDACurrent
62011-0030health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0214Health Mart Childrens IbuprofenIbuprofenMcKessonANDACurrent
62011-0214Health Mart Childrens IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
63940-219core values childrens ibuprofenIbuprofenHarmon Stores Inc.ANDACurrent
63940-897harmon face values ibuprofenIbuprofenHarmon Stores Inc.ANDACurrent
63940-897harmon face values ibuprofenIbuprofenHarmon Stores Inc.ANDACurrent
63940-897harmon face values ibuprofenIbuprofenHarmon Stores Inc.ANDACurrent
64024-003Welby Childrens IbuprofenIbuprofenAldi, IncANDACurrent
68094-037Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-494Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-494Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-494Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-503Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-503Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-503Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-600Dye Free Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68094-600Dye Free Childrens IbuprofenIbuprofenPrecision Dose Inc.ANDACurrent
68391-685Berkley and Jensen ibuprofenIbuprofenBJWCANDACurrent
68391-897Berkley and Jensen Childrens IbuprofenIbuprofenBJWCANDACurrent
68391-897Berkley and Jensen Childrens IbuprofenIbuprofenBJWCANDACurrent
68788-9810IbuprofenIbuprofenPreferred Pharmaceuticals, IncANDACurrent
69256-166Harris Teeter Childrens IbuprofenIbuprofenHarris Teeter, LLCANDACurrent
69256-660Harris Teeter Childrens IbuprofenIbuprofenHarris Teeter, LLCANDACurrent
69256-897Harris Teeter Childrens IbuprofenIbuprofenHarris Teeter, LLCANDACurrent
69842-323Childrens IbuprofenIbuprofenCVS PharmacyANDACurrent
70000-0181Leader Childrens IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0181Leader Childrens IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0262Leader IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0262Leader IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0263LEADER CHILDRENS IBUPROFENIbuprofenCardinal HealthANDACurrent
70000-0263LEADER CHILDRENS IBUPROFENIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0264leader IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0264leader IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70925-897Humana Pharmacy Childrens IbuprofenIbuprofenHumana Pharmacy, Inc.ANDACurrent
71141-011IbuprofenIbuprofenLidl US LLCANDACurrent
71205-395ibuprofenIbuprofenProficient Rx LPANDACurrent
72288-166basic care childrens ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-660basic care childrens ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-685basic care childrens ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-897basic care childrens ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-897basic care childrens ibuprofenIbuprofenAmazon.com Services Inc.ANDACurrent
72288-897basic care childrens ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
81522-897caring mill childrens ibuprofenIbuprofenFSA Store Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39446ORIG1998-12-22
22386ORIG1998-12-22
8469ORIG1998-12-22