Home NDC 0363-9131 Acetaminophen and Ibuprofen
Product NDC 0363-9131
11-digit product format 003639131
Labeler code 0363
Product ID 0363-9131_4653ceee-cd77-c747-e063-6294a90a95b1
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen
Dosage form TABLET
Route ORAL
Labeler WALGREENS
Application ANDA216592
Marketing category ANDA
Marketing start 2023-07-19
Substance ACETAMINOPHEN; IBUPROFEN
Active strength 250; 125 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 1 .
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 A216592-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 IBUPROFEN 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup WK2XYI10QM 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-9131-16 Acetaminophen and Ibuprofen 216 in 1 BOTTLE TABLET 216 5 0363-9131-44 Acetaminophen and Ibuprofen 144 in 1 BOTTLE TABLET 144 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9131 ACETAMINOPHEN AND IBUPROFEN TABLET [WALGREENS] 4 Current NDC, 2 package rows 20241218_e457af7c-0fa7-a47e-e053-2a95a90abf9c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0363-9131-16 00363913116 216 TABLET in 1 BOTTLE (0363-9131-16) 216 tablet 2023-07-19 No No Current 0363-9131-44 00363913144 144 TABLET in 1 BOTTLE (0363-9131-44) 144 tablet 2023-07-19 No No Current