diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hcl
Labeler rugby laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1214
Product ID 0536-1214_c0b8fd3b-609b-4b55-a447-670d19f77821
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-03-28

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 05361214
Hyphenated Format 0536-1214

Supplemental Identifiers

RxCUI
1049630
UPC
0305361214296
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 diphenhydramine hcl (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1214-29)
source: ndc

Packages (1)

0536-1214-29 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1214-29)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c0b8fd3b-609b-4b55-a447-670d19f77821", "openfda": {"upc": ["0305361214296"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["6c4f280d-9a98-40c3-a459-4220cf34c313"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1214-29)", "package_ndc": "0536-1214-29", "marketing_start_date": "20190328"}], "brand_name": "Diphenhydramine HCl", "product_id": "0536-1214_c0b8fd3b-609b-4b55-a447-670d19f77821", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0536-1214", "generic_name": "Diphenhydramine HCl", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190328", "listing_expiration_date": "20261231"}