Home NDC 50580-534 Childrens Benadryl ALLERGY
Product NDC 50580-534
11-digit product format 505800534
Labeler code 50580
Product ID 50580-534_5b322e17-68d7-7008-e063-6394a90a36c9
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 2027-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 ALLERGY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 50580-534-04 Childrens Benadryl ALLERGY 1 in 1 CARTON SOLUTION 1 13 50580-534-04 Childrens Benadryl ALLERGY 118 mL in 1 BOTTLE SOLUTION 118 13 50580-534-08 Childrens Benadryl ALLERGY 236 mL in 1 BOTTLE SOLUTION 236 13 50580-534-08 Childrens Benadryl ALLERGY 1 in 1 CARTON SOLUTION 1 13 50580-534-16 Childrens Benadryl ALLERGY 2 in 1 PACKAGE SOLUTION 2 13 50580-534-16 Childrens Benadryl ALLERGY 1 in 1 CARTON SOLUTION 1 13 50580-534-18 Childrens Benadryl ALLERGY 2 in 1 PACKAGE SOLUTION 2 13 50580-534-18 Childrens Benadryl ALLERGY 1 in 1 CARTON SOLUTION 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Diphenhydramine hydrochloride ACTIVE INGREDIENT TC2D6JAD40 CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 diphenhydramine ACTIVE MOIETY 8GTS82S83M CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 ammonium glycyrrhizate INACTIVE INGREDIENT 3VRD35U26C CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 D&C red no. 33 INACTIVE INGREDIENT 9DBA0SBB0L CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 poloxamer 407 INACTIVE INGREDIENT TUF2IVW3M2 CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 sucrose INACTIVE INGREDIENT C151H8M554 CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-534 CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] 13 Current NDC, Legacy NDC, 8 package rows 20250515_fc9181b9-c92d-493e-8d7c-4a4239c6c092.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 50580-534-04 50580053404 1 BOTTLE in 1 CARTON (50580-534-04) / 118 mL in 1 BOTTLE 1 bottle 2008-07-01 0000-00-00 No No Current 50580-534-08 50580053408 1 BOTTLE in 1 CARTON (50580-534-08) / 236 mL in 1 BOTTLE 1 bottle 2008-07-01 0000-00-00 No No Current 50580-534-16 50580053416 2 CARTON in 1 PACKAGE (50580-534-16) > 1 BOTTLE in 1 CARTON > 236 mL in 1 BOTTLE 2 carton 2009-01-28 0000-00-00 No No Current 50580-534-18 50580053418 2 CARTON in 1 PACKAGE (50580-534-18) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE 2 carton 2021-04-12 0000-00-00 No No Current