benadryl allergy extra strength

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 extra strength
Generic Name diphenhydramine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-533
Product ID 50580-533_21731b98-004e-db35-e063-6394a90a8397
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-07-05

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 50580533
Hyphenated Format 50580-533

Supplemental Identifiers

RxCUI
1085945 2605033
UPC
0300450235244
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 extra strength (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-533-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-533-24 2 BLISTER PACK in 1 CARTON (50580-533-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Benadryl Allergy EXTRA STRENGTH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21731b98-004e-db35-e063-6394a90a8397", "openfda": {"upc": ["0300450235244"], "unii": ["TC2D6JAD40"], "rxcui": ["1085945", "2605033"], "spl_set_id": ["dd0a8069-18d8-5696-e053-2995a90a2f22"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-533-24)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-533-24", "marketing_start_date": "20220705"}], "brand_name": "Benadryl Allergy EXTRA STRENGTH", "product_id": "50580-533_21731b98-004e-db35-e063-6394a90a8397", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-533", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Benadryl Allergy EXTRA STRENGTH", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220705", "listing_expiration_date": "20261231"}