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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 84 · 1,678 matching rows.
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
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