benadryl

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

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

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-226
Product ID 50580-226_4a24745b-a44e-fbeb-e063-6394a90abd0a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2008-09-01

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 50580226
Hyphenated Format 50580-226

Supplemental Identifiers

RxCUI
1049630 1049632
UPC
0300450171122
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 (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50580-226-12) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 CARTON in 1 CARTON (50580-226-20) / 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
  • 3 CARTON in 1 CARTON (50580-226-33) / 1 BOTTLE in 1 CARTON / 48 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-226-50) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (50580-226-51) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50580-226-52) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 TABLET, FILM COATED in 1 POUCH (50580-226-53)
  • 60 POUCH in 1 CARTON (50580-226-54) / 2 TABLET, FILM COATED in 1 POUCH
  • 3 CARTON in 1 PACKAGE (50580-226-56) / 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 POUCH in 1 CARTON (50580-226-62) / 2 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE in 1 CARTON (50580-226-70) / 48 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (11)

50580-226-12 1 BLISTER PACK in 1 CARTON (50580-226-12) / 12 TABLET, FILM COATED in 1 BLISTER PACK 50580-226-20 2 CARTON in 1 CARTON (50580-226-20) / 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE 50580-226-33 3 CARTON in 1 CARTON (50580-226-33) / 1 BOTTLE in 1 CARTON / 48 TABLET, FILM COATED in 1 BOTTLE 50580-226-50 1 BOTTLE in 1 CARTON (50580-226-50) / 100 TABLET, FILM COATED in 1 BOTTLE 50580-226-51 2 BLISTER PACK in 1 CARTON (50580-226-51) / 12 TABLET, FILM COATED in 1 BLISTER PACK 50580-226-52 4 BLISTER PACK in 1 CARTON (50580-226-52) / 12 TABLET, FILM COATED in 1 BLISTER PACK 50580-226-53 2 TABLET, FILM COATED in 1 POUCH (50580-226-53) 50580-226-54 60 POUCH in 1 CARTON (50580-226-54) / 2 TABLET, FILM COATED in 1 POUCH 50580-226-56 3 CARTON in 1 PACKAGE (50580-226-56) / 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK 50580-226-62 4 POUCH in 1 CARTON (50580-226-62) / 2 TABLET, FILM COATED in 1 POUCH 50580-226-70 1 BOTTLE in 1 CARTON (50580-226-70) / 48 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Benadryl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a24745b-a44e-fbeb-e063-6394a90abd0a", "openfda": {"upc": ["0300450171122"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630", "1049632"], "spl_set_id": ["702f9786-7ce9-43e4-921d-e1db09612127"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-226-12)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-226-12", "marketing_start_date": "20250611"}, {"sample": false, "description": "2 CARTON in 1 CARTON (50580-226-20)  / 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-226-20", "marketing_start_date": "20240115"}, {"sample": false, "description": "3 CARTON in 1 CARTON (50580-226-33)  / 1 BOTTLE in 1 CARTON / 48 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-226-33", "marketing_start_date": "20250728"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-226-50)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-226-50", "marketing_start_date": "20120604"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-226-51)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-226-51", "marketing_start_date": "20120604"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-226-52)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-226-52", "marketing_start_date": "20120604"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 POUCH (50580-226-53)", "package_ndc": "50580-226-53", "marketing_start_date": "20120604"}, {"sample": false, "description": "60 POUCH in 1 CARTON (50580-226-54)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-226-54", "marketing_start_date": "20150727"}, {"sample": false, "description": "3 CARTON in 1 PACKAGE (50580-226-56)  / 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-226-56", "marketing_start_date": "20130201"}, {"sample": false, "description": "4 POUCH in 1 CARTON (50580-226-62)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-226-62", "marketing_start_date": "20170102"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-226-70)  / 48 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-226-70", "marketing_start_date": "20250602"}], "brand_name": "Benadryl", "product_id": "50580-226_4a24745b-a44e-fbeb-e063-6394a90abd0a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-226", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Benadryl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080901", "listing_expiration_date": "20271231"}