FDA.reportPublic FDA data

Application 216592

Type
ANDA
Sponsor
GRANULES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFENTABLET;ORAL250MG;125MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A216592-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-138072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-139b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13a50c72e98297…

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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Period Pills by BiikayACETAMINOPHEN, IBUPROFENKai Squared40d2ae73-82cf-3fa1-e063-6394a90a9ea22026-06-01WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWAL-MART STORES INC.0aaddde9-4317-a828-e063-6294a90a26d52025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RETAIL BUSINESS SERVICES,LLCe7b7009a-89a4-720d-e053-2a95a90abff72025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
AcetaminophenACETAMINOPHENRAONBIO CORPf6f5251d-db89-4b69-e053-6394a90a10282025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENLEADER/ Cardinal Health 110, Inc.f1d69088-4d52-cbb5-e053-2995a90a3ec82025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENRUGBY LABORATORIESed340993-04e6-b084-e053-2a95a90abf602025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWALGREENSe457af7c-0fa7-a47e-e053-2a95a90abf9c2025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVSe45830a0-c884-e556-e053-2995a90ab5652025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVSf0d3f0ab-07ee-f068-e053-2995a90a481a2025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENFamily Dollarfe095058-5ecb-75b3-e053-6394a90afb6c2025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RITE AIDe64c0ec1-2889-96d1-e053-2995a90a85682025-12-19WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVS2f3a6c80-0b84-c469-e063-6394a90aea8e2025-07-01WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENGranules Pharmaceuticals Inc.0f8b9524-8fe3-47cf-bacd-93047442d90d2025-06-03WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and Ibuprofen Back PainACETAMINOPHEN AND IBUPROFENGranules Pharmaceuticals Inc.32562aa1-f44b-649e-e063-6394a90a47c82025-04-09WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Aacetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENGRANULES USA, INC.1dd90684-6505-8e07-e063-6394a90afdf42024-12-26WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Dual Action Pain ReliefDUAL ACTION PAIN RELIEFAllegiant Healthfb4fc347-0f90-429f-9ca8-903e736f54962024-03-29WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)Wal-Mart Stores Inc.e7b36e3c-0e8a-1aeb-e053-2995a90a51a42023-07-17WarningsExact identifier
application applno (ANDA): 216592
application number: ANDA216592