Home NDC 0363-9664 Acetaminophen Diphenhydramine HCL
Product NDC 0363-9664
11-digit product format 003639664
Labeler code 0363
Product ID 0363-9664_46537594-decc-ce80-e063-6394a90aa159
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler WALGREENS CO.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-30
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 0363-9664-37 Acetaminophen Diphenhydramine HCL 375 in 1 BOTTLE TABLET 375 7 0363-9664-60 Acetaminophen Diphenhydramine HCL 125 in 1 BOTTLE TABLET 125 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9664 ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [WALGREENS CO.] 6 Current NDC, Legacy NDC, 2 package rows 20241220_d92d97a8-0ee3-1206-e053-2a95a90a72a8.zip
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 0363-9664-37 00363966437 375 TABLET in 1 BOTTLE (0363-9664-37) 375 tablet 2024-07-13 No No Current 0363-9664-60 00363966460 125 TABLET in 1 BOTTLE (0363-9664-60) 125 tablet 2022-09-30 0000-00-00 No No Current