Home NDC 0363-2012 WALGREENS
Product NDC 0363-2012
11-digit product format 003632012
Labeler code 0363
Product ID 0363-2012_38c863cb-f534-0b3d-e063-6294a90aa8db
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler WALGREENS CO.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-09
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 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 WALGREENS
Brand name suffix Dye Free Chidrens Allergy Chews
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1049900 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 0363-2012-20 WALGREENSDye Free Chidrens Allergy Chews 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 1 0363-2012-20 WALGREENSDye Free Chidrens Allergy Chews 2 in 1 CARTON TABLET, CHEWABLE 2 1
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 98 of 180 · 3,583 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 0363-2012-20 00363201220 2 BLISTER PACK in 1 CARTON (0363-2012-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2025-06-09 No No Current