Home NDC 51316-955-11 Acetaminophen and Ibuprofen
Product NDC 51316-955
Requested package NDC 51316-955-11
11-digit product format 513160955
Labeler code 51316
Product ID 51316-955_570ebcac-82c8-04d2-e063-6294a90a9313
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS Pharmacy
Application ANDA216999
Marketing category ANDA
Marketing start 2026-07-20
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 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216999-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 a50c72e98297…
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 125 mg/1 ACETAMINOPHEN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 12 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-955-11 51316095511 1 BOTTLE in 1 CARTON (51316-955-11) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-07-20 No No Current