Home NDC 57631-010 Acetaminophen and Diphenhydramine citrate
Product NDC 57631-010
11-digit product format 576310010
Labeler code 57631
Product ID 57631-010_403a87a6-fe92-8e79-e063-6394a90a70ce
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine citrate
Dosage form TABLET
Route ORAL
Labeler InvaTech Pharma Solutions LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE
Active strength 500; 38 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 and Diphenhydramine citrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE CITRATE 38 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 4OD433S209 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099872 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 57631-010-00 Acetaminophen and Diphenhydramine citrate 30000 in 1 BOX TABLET 30000 4
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 73 of 178 · 3,551 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 57631-010-00 57631001000 30000 TABLET in 1 BOX (57631-010-00) 30000 tablet 2025-10-01 No No Current