Home NDC 50580-535 Childrens Benadryl DYE-FREE ALLERGY
Product NDC 50580-535
11-digit product format 505800535
Labeler code 50580
Product ID 50580-535_27d44a57-0879-63ea-e063-6394a90ac4cf
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 2008-07-01
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 Childrens Benadryl DYE-FREE 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-535-01 Childrens Benadryl DYE-FREE ALLERGY 118 mL in 1 BOTTLE SOLUTION 118 10 50580-535-01 Childrens Benadryl DYE-FREE ALLERGY 1 in 1 CARTON SOLUTION 1 10 50580-535-02 Childrens Benadryl DYE-FREE ALLERGY 1 in 1 CARTON SOLUTION 1 10 50580-535-02 Childrens Benadryl DYE-FREE ALLERGY 2 in 1 PACKAGE SOLUTION 2 10 50580-535-08 Childrens Benadryl DYE-FREE ALLERGY 236 mL in 1 BOTTLE SOLUTION 236 10 50580-535-08 Childrens Benadryl DYE-FREE ALLERGY 1 in 1 CARTON SOLUTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-535 CHILDRENS BENADRYL DYE-FREE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] 10 Current NDC, Legacy NDC, 6 package rows 20241204_10d478ff-ddc6-45da-87ff-cfe1b2b07a8e.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 Marketing end Sample Exclude flag Status 50580-535-01 50580053501 1 BOTTLE in 1 CARTON (50580-535-01) / 118 mL in 1 BOTTLE 1 bottle 2015-12-01 0000-00-00 No No Current 50580-535-02 50580053502 2 CARTON in 1 PACKAGE (50580-535-02) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE 2 carton 2024-11-18 No No Current 50580-535-08 50580053508 1 BOTTLE in 1 CARTON (50580-535-08) / 236 mL in 1 BOTTLE 1 bottle 2022-06-16 0000-00-00 No No Current