benadryl

Generic: diphenhydramine hydrochloride

Labeler: morning star otc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name benadryl
Generic Name diphenhydramine hydrochloride
Labeler morning star otc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Morning Star OTC

Identifiers & Regulatory

Product NDC 53209-3001
Product ID 53209-3001_371fa3fe-9460-112b-e063-6294a90afe82
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-09

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 532093001
Hyphenated Format 53209-3001

Supplemental Identifiers

RxCUI
1049630 1049632
UNII
TC2D6JAD40

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
  • 25 BLISTER PACK in 1 PACKET (53209-3001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-3001-1)
source: ndc

Packages (1)

53209-3001-2 25 BLISTER PACK in 1 PACKET (53209-3001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-3001-1)

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": "371fa3fe-9460-112b-e063-6294a90afe82", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630", "1049632"], "spl_set_id": ["f4ff84b3-bb0c-4900-8ba4-6d1b90394782"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "25 BLISTER PACK in 1 PACKET (53209-3001-2)  / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-3001-1)", "package_ndc": "53209-3001-2", "marketing_start_date": "20250609"}], "brand_name": "Benadryl", "product_id": "53209-3001_371fa3fe-9460-112b-e063-6294a90afe82", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53209-3001", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Morning Star OTC", "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": "20250609", "listing_expiration_date": "20261231"}