FDA.reportPublic FDA data

Application 214836

Type
ANDA
Sponsor
L PERRIGO CO

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
A214836-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28

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 UTC2026-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a50c72e98297…

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dual actionACETAMINOPHEN, IBUPROFENPublix Super Markets Ince185d119-3484-40b1-afb8-6dca49d45e402026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dual pain relieverACETAMINOPHEN, IBUPROFENMeijer, Inc.db1dc4f6-23ec-4a04-baa8-ffa739bce76a2026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
DUAL ACTIONACETAMINOPHEN, IBUPROFENAmazon.com Services LLC20fe6b3f-e5a6-47d4-a371-9172408fbc462026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
acetaminophen and ibuprofenACETAMINOPHEN, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
topcare dual actionACETAMINOPHEN, IBUPROFENTopco Associates LLCdddc04c4-d500-4d42-8406-89f27a9ad6512026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
DUAL ACTION BACK PAIN RELIEVERACETAMINOPHEN, IBUPROFENMeijer, Inc.8d9a0c56-ef22-45a6-8b1d-d2b2f32472102026-03-19WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
DUAL ACTIONACETAMINOPHEN, IBUPROFENHyVee Inc9cec2952-6f40-4352-8ffd-b46988b7df312026-03-18WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
good sense dual actionACETAMINOPHEN, IBUPROFENSportpharm LLC3f4ade2c-56e0-4aab-910e-73c26546a4d72026-02-06WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Motrin Dual Action With TylenolACETAMINOPHEN AND IBUPROFENKenvue Brands LLCf2ee9cf5-02b7-6612-e053-2995a90a90c42026-02-03WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
equate dual pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.09dc976b-6065-4aad-9d57-0fe5e88a722a2025-12-15WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702025-11-03WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2025-09-30WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
CAREONE DUAL ACTIONACETAMINOPHEN, IBUPROFENRetail Business Services, LLC76302cb3-0371-49ce-85d8-5f3785c370b02025-08-25WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2025-08-08WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dg health dual back pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Incb52cfead-1cff-4e11-9953-f470fb785c732025-07-07WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2025-06-05WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
equate dual back pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.af7e6478-177f-473d-9d14-1e78610b1a6e2025-05-17WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2024-11-20WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2024-03-25WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73755ORIG 2023-03-14