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 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 50580-573
Product ID 50580-573_2cc68544-e514-f895-e063-6394a90aa577
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-02

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 50580573
Hyphenated Format 50580-573

Supplemental Identifiers

RxCUI
1049906 1049908
UPC
0300450534248
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 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 (50580-573-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-573-04 1 BOTTLE in 1 CARTON (50580-573-04) / 118 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

BENADRYL Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cc68544-e514-f895-e063-6394a90aa577", "openfda": {"upc": ["0300450534248"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906", "1049908"], "spl_set_id": ["224ba2a3-1a93-29c8-e063-6394a90a9bef"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-573-04)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-573-04", "marketing_start_date": "20241202"}], "brand_name": "BENADRYL Allergy", "product_id": "50580-573_2cc68544-e514-f895-e063-6394a90aa577", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-573", "generic_name": "Diphenhydramine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BENADRYL Allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241202", "listing_expiration_date": "20261231"}