Home NDC 0363-9835 Diphenhydramine Hydrochloride
Product NDC 0363-9835
11-digit product format 003639835
Labeler code 0363
Product ID 0363-9835_5c90c46c-9450-cc10-e063-6294a90ace65
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Walgreen Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-07
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Diphenhydramine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-9835-01 Diphenhydramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 4 0363-9835-01 Diphenhydramine Hydrochloride 1 in 1 CARTON CAPSULE 1 4 0363-9835-02 Diphenhydramine Hydrochloride 600 in 1 BOTTLE CAPSULE 600 4 0363-9835-06 Diphenhydramine Hydrochloride 365 in 1 BOTTLE CAPSULE 365 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9835 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [WALGREEN COMPANY] 4 Current NDC, Legacy NDC, 4 package rows 20241208_beb34c94-8370-e97d-e053-2995a90a59cc.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 97 of 178 · 3,550 matching rows.
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 0363-9835-01 00363983501 1 BOTTLE in 1 CARTON (0363-9835-01) > 100 CAPSULE in 1 BOTTLE 1 bottle 2021-09-07 0000-00-00 No No Current 0363-9835-02 00363983502 600 CAPSULE in 1 BOTTLE (0363-9835-02) 600 capsule 2022-05-05 0000-00-00 No No Current 0363-9835-06 00363983506 365 CAPSULE in 1 BOTTLE (0363-9835-06) 365 capsule 2021-10-01 0000-00-00 No No Current