childrens benadryl dye-free 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 dye-free 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 50580-535
Product ID 50580-535_27d44a57-0879-63ea-e063-6394a90ac4cf
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 50580535
Hyphenated Format 50580-535

Supplemental Identifiers

RxCUI
1049906 1049908
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 dye-free 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 (50580-535-01) / 118 mL in 1 BOTTLE
  • 2 CARTON in 1 PACKAGE (50580-535-02) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-535-08) / 236 mL in 1 BOTTLE
source: ndc

Packages (3)

50580-535-01 1 BOTTLE in 1 CARTON (50580-535-01) / 118 mL in 1 BOTTLE 50580-535-02 2 CARTON in 1 PACKAGE (50580-535-02) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE 50580-535-08 1 BOTTLE in 1 CARTON (50580-535-08) / 236 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Childrens Benadryl DYE-FREE ALLERGY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27d44a57-0879-63ea-e063-6394a90ac4cf", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906", "1049908"], "spl_set_id": ["10d478ff-ddc6-45da-87ff-cfe1b2b07a8e"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-535-01)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-535-01", "marketing_start_date": "20151201"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-535-02)  / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE", "package_ndc": "50580-535-02", "marketing_start_date": "20241118"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-535-08)  / 236 mL in 1 BOTTLE", "package_ndc": "50580-535-08", "marketing_start_date": "20220616"}], "brand_name": "Childrens Benadryl DYE-FREE ALLERGY", "product_id": "50580-535_27d44a57-0879-63ea-e063-6394a90ac4cf", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-535", "generic_name": "Diphenhydramine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Benadryl DYE-FREE 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"}