childrens benadryl allergy

Generic: diphenhydramine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens benadryl allergy
Generic Name diphenhydramine hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-534
Product ID 50580-534_35026484-5305-5f3d-e063-6294a90a5a50
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2008-07-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580534
Hyphenated Format 50580-534

Supplemental Identifiers

RxCUI
1049906 1049908
UPC
0350580534045
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens benadryl allergy (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-534-04) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-534-08) / 236 mL in 1 BOTTLE
  • 2 CARTON in 1 PACKAGE (50580-534-18) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE
source: ndc

Packages (3)

50580-534-04 1 BOTTLE in 1 CARTON (50580-534-04) / 118 mL in 1 BOTTLE 50580-534-08 1 BOTTLE in 1 CARTON (50580-534-08) / 236 mL in 1 BOTTLE 50580-534-18 2 CARTON in 1 PACKAGE (50580-534-18) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Childrens Benadryl ALLERGY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35026484-5305-5f3d-e063-6294a90a5a50", "openfda": {"upc": ["0350580534045"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906", "1049908"], "spl_set_id": ["fc9181b9-c92d-493e-8d7c-4a4239c6c092"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-534-04)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-534-04", "marketing_start_date": "20080701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-534-08)  / 236 mL in 1 BOTTLE", "package_ndc": "50580-534-08", "marketing_start_date": "20080701"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-534-18)  / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE", "package_ndc": "50580-534-18", "marketing_start_date": "20210412"}], "brand_name": "Childrens Benadryl ALLERGY", "product_id": "50580-534_35026484-5305-5f3d-e063-6294a90a5a50", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-534", "generic_name": "Diphenhydramine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Benadryl ALLERGY", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080701", "listing_expiration_date": "20261231"}