Home NDC 0904-6731 Acetaminophen PM
Product NDC 0904-6731
11-digit product format 009046731
Labeler code 0904
Product ID 0904-6731_52fac64b-8e53-d7b7-e063-6294a90a3b71
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-26
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 25; 500 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 PM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 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 1092189 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 0904-6731-51 Acetaminophen, Diphenhydramine Hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 5 0904-6731-51 Acetaminophen, Diphenhydramine Hydrochloride 50 in 1 BOTTLE TABLET, FILM COATED 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6731 ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20240131_786dbcd5-f5c2-4491-e053-2991aa0a3437.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 63 of 79 · 1,576 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6731-51 00904673151 1 BOTTLE in 1 CARTON (0904-6731-51) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-12-26 0000-00-00 No No Current