Home NDC 50090-7014 Diphenhydramine Hydrochloride
Product NDC 50090-7014
11-digit product format 500907014
Labeler code 50090
Product ID 50090-7014_59ecc4f3-dc0e-4d7e-a47c-f00601d9228c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-14
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 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 Diphenhydramine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 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 1049909 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 50090-7014-0 Diphenhydramine Hydrochloride 10 in 1 BOX, UNIT-DOSE CAPSULE 10 3 50090-7014-0 Diphenhydramine Hydrochloride 10 in 1 BLISTER PACK CAPSULE 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7014 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS] 3 Current NDC, 2 package rows 20240314_5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2.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 74 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 50090-7014-0 50090701400 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-7014-0) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2024-01-04 No No Current