Diphenhydramine hydrochloride

Generic: Diphenhydramine hydrochloride

Labeler: Elysium Pharmaceuticals Ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Active

Drug Facts

Product Profile

Brand Name Diphenhydramine hydrochloride
Generic Name Diphenhydramine hydrochloride
Labeler Elysium Pharmaceuticals Ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

Identifiers & Regulatory

Product NDC 14803-273
Product ID 14803-273_487a7d84-8594-361b-e063-6294a90a13e1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-03-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14803273
Hyphenated Format 14803-273

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 Diphenhydramine hydrochloride (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
  • 100000 TABLET, FILM COATED in 1 BOTTLE (14803-273-00)
source: ndc

Packages (1)

14803-273-00 100000 TABLET, FILM COATED in 1 BOTTLE (14803-273-00)

Ingredients (1)

DIPHENHYDRAMINE HYDROCHLORIDE (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "487a7d84-8594-361b-e063-6294a90a13e1", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["131977ed-f1cb-1378-e063-6394a90ae815"], "manufacturer_name": ["Elysium Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100000 TABLET, FILM COATED in 1 BOTTLE (14803-273-00)", "package_ndc": "14803-273-00", "marketing_start_date": "20240307"}], "brand_name": "Diphenhydramine hydrochloride", "product_id": "14803-273_487a7d84-8594-361b-e063-6294a90a13e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "14803-273", "generic_name": "Diphenhydramine hydrochloride", "labeler_name": "Elysium Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240307", "listing_expiration_date": "20271231"}