Home NDC 0904-7319 Acetaminophen
Product NDC 0904-7319
11-digit product format 009047319
Labeler code 0904
Product ID 0904-7319_fb29cf09-7587-42fb-8537-f729fb7557ac
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-05
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 307675 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 0904-7319-41 Acetaminophen 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 14 0904-7319-70 Acetaminophen 10 in 1 CASE SOLUTION 10 14 0904-7319-70 Acetaminophen 10 in 1 TRAY SOLUTION 10 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7319 ACETAMINOPHEN SOLUTION [MAJOR PHARMACEUTICALS] 14 Current NDC, 3 package rows 20250125_32ea1230-f9ae-46b0-910e-05cd187cee34.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 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 0904-7319-41 00904731941 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0904-7319-70 00904731970 10 TRAY in 1 CASE (0904-7319-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7319-41) 10 tray 2023-06-05 No No Current