diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: simpex pharma pvt. ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler simpex pharma pvt. ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Simpex Pharma Pvt. Ltd

Identifiers & Regulatory

Product NDC 76457-002
Product ID 76457-002_0b586170-9b5f-74dc-e063-6394a90aa09b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-02-09

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 76457002
Hyphenated Format 76457-002

Supplemental Identifiers

RxCUI
1049630
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 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
  • 1 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

76457-002-00 1 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLE

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": "0b586170-9b5f-74dc-e063-6394a90aa09b", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["82771f6a-8b3d-4ffa-8b35-09c2faf3582c"], "manufacturer_name": ["Simpex Pharma Pvt. Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76457-002-00)  / 100 TABLET in 1 BOTTLE", "package_ndc": "76457-002-00", "marketing_start_date": "20180209"}], "brand_name": "diphenhydramine hydrochloride", "product_id": "76457-002_0b586170-9b5f-74dc-e063-6394a90aa09b", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76457-002", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Simpex Pharma Pvt. 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": "20180209", "listing_expiration_date": "20261231"}