Home NDC 0363-9799 Acetaminophen Diphenhydramine HCL
Product NDC 0363-9799
11-digit product format 003639799
Labeler code 0363
Product ID 0363-9799_4653cf42-f61c-31a9-e063-6394a90a00a8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler WALGREEN CO.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-03
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 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 Diphenhydramine HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 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 TC2D6JAD40 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 0363-9799-75 Acetaminophen Diphenhydramine HCL 75 in 1 BOTTLE TABLET 75 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9799 ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [WALGREEN CO.] 4 Current NDC, 1 package rows 20241218_b3763182-2428-155a-e053-2995a90ab578.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 78 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 Sample Exclude flag Status 0363-9799-75 00363979975 75 TABLET in 1 BOTTLE (0363-9799-75) 75 tablet 2023-03-03 No No Current