Home NDC 50580-232 Childrens Benadryl Chewables
Product NDC 50580-232
11-digit product format 505800232
Labeler code 50580
Product ID 50580-232_215db1b4-b8fb-90be-e063-6294a90a6353
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-11
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 Childrens Benadryl Chewables
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049900 Internal RxNorm lookup 1049901 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 50580-232-01 Childrens Benadryl Chewables 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 7 50580-232-01 Childrens Benadryl Chewables 2 in 1 CARTON TABLET, CHEWABLE 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-232 CHILDRENS BENADRYL CHEWABLES (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241109_b08f71d8-a06c-41ba-8ed1-fbc41dbc1919.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 99 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 50580-232-01 50580023201 2 BLISTER PACK in 1 CARTON (50580-232-01) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2016-07-11 0000-00-00 No No Current