Home NDC 70264-040 Acetaminophen 250 mg and Ibuprofen 125 mg
Product NDC 70264-040
11-digit product format 702640040
Labeler code 70264
Product ID 70264-040_43c8f4e2-0cd4-448f-e063-6394a90a3a88
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 250 mg and Ibuprofen 125 mg
Dosage form TABLET, FILM COATED
Route ORAL
Labeler R J General Corporation
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-30
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 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 250 mg and Ibuprofen 125 mg
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 70264-040-12 Acetaminophen 250 mg and Ibuprofen 125 mg 50 in 1 CARTON TABLET, FILM COATED 50 2 70264-040-12 Acetaminophen 250 mg and Ibuprofen 125 mg 2 in 1 POUCH TABLET, FILM COATED 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70264-040 ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLET, FILM COATED [R J GENERAL CORPORATION] 1 Current NDC, 2 package rows 20241116_68d3be55-9340-4cc9-a05a-12b9338ddc56.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 64 of 79 · 1,579 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 70264-040-12 70264004012 50 POUCH in 1 CARTON (70264-040-12) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2024-10-30 No No Current