Home NDC 0363-9661 Acetaminophen Diphenhydramine HCL
Product NDC 0363-9661
11-digit product format 003639661
Labeler code 0363
Product ID 0363-9661_46545016-29d1-7e81-e063-6294a90a941f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler Walgreens
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-23
Substance ACETAMINOPHEN; DIPHENHYDRAMINE
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 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 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 8GTS82S83M 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 0363-9661-15 Acetaminophen Diphenhydramine HCL 150 in 1 BOTTLE TABLET 150 4 0363-9661-25 Acetaminophen Diphenhydramine HCL 250 in 1 BOTTLE TABLET 250 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9661 ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [WALGREENS] 3 Current NDC, 2 package rows 20241222_fd7c3250-35d4-494a-e053-6394a90a2db5.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 1 of 85 · 1,681 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 0363-9661-15 00363966115 150 TABLET in 1 BOTTLE (0363-9661-15) 150 tablet 2024-07-23 No No Current 0363-9661-25 00363966125 250 TABLET in 1 BOTTLE (0363-9661-25) 250 tablet 2024-07-23 No No Current