FDA.reportPublic FDA data

Acetaminophen and Ibuprofen (NSAID)

Product NDC
11822-1131
11-digit product format
118221131
Labeler code
11822
Product ID
11822-1131_4654faae-9084-7bb5-e063-6394a90acca2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Ibuprofen (NSAID)
Dosage form
TABLET
Route
ORAL
Labeler
RITE AID
Application
ANDA216592
Marketing category
ANDA
Marketing start
2023-07-21
Substance
IBUPROFEN; ACETAMINOPHEN
Active strength
125; 250 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
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
2026-09-14 22:38:342026-08A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1384e616aacf4f…
2026-08-18 06:07:402026-07A216592-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-13caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Ibuprofen (NSAID)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN125 mg/1
ACETAMINOPHEN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387532Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e64c0ec1-2889-96d1-e053-2995a90a8568Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1131-4Acetaminophen and Ibuprofen (NSAID)144 in 1 BOTTLETABLET1445
11822-1131-6Acetaminophen and Ibuprofen (NSAID)216 in 1 BOTTLETABLET2165

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1131ACETAMINOPHEN AND IBUPROFEN (NSAID) TABLET [RITE AID]4Current NDC, 2 package rows20241226_e64c0ec1-2889-96d1-e053-2995a90a8568.zip

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
ndc (product): 11822-1131
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNe64c0ec1-2889-96d1-e053-2995a90a85685
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDe64c0ec1-2889-96d1-e053-2995a90a85685
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYe64c0ec1-2889-96d1-e053-2995a90a85685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-1131-411822113104144 TABLET in 1 BOTTLE (11822-1131-4) 144 tablet2023-07-21NoNoCurrent
11822-1131-611822113106216 TABLET in 1 BOTTLE (11822-1131-6) 216 tablet2023-07-21NoNoCurrent