Home NDC 50580-573 BENADRYL Allergy
Product NDC 50580-573
11-digit product format 505800573
Labeler code 50580
Product ID 50580-573_2cc68544-e514-f895-e063-6394a90aa577
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-02
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 BENADRYL Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049906 Internal RxNorm lookup 1049908 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 50580-573-04 BENADRYL Allergy 1 in 1 CARTON SOLUTION 1 3 50580-573-04 BENADRYL Allergy 118 mL in 1 BOTTLE SOLUTION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-573 BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] 3 Current NDC, 2 package rows 20250131_224ba2a3-1a93-29c8-e063-6394a90a9bef.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 50580-573-04 50580057304 1 BOTTLE in 1 CARTON (50580-573-04) / 118 mL in 1 BOTTLE 1 bottle 2024-12-02 No No Current