diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: bi-mart
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler bi-mart
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Bi-Mart

Identifiers & Regulatory

Product NDC 37835-641
Product ID 37835-641_38f71fd9-448b-95d3-e063-6294a90a3523
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

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 37835641
Hyphenated Format 37835-641

Supplemental Identifiers

RxCUI
1049630
UPC
0071357006915
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
  • 100 TABLET in 1 BOTTLE (37835-641-01)
source: ndc

Packages (1)

37835-641-01 100 TABLET in 1 BOTTLE (37835-641-01)

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": "38f71fd9-448b-95d3-e063-6294a90a3523", "openfda": {"upc": ["0071357006915"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["2e7a9032-67d6-d408-e063-6394a90aca8c"], "manufacturer_name": ["Bi-Mart"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (37835-641-01)", "package_ndc": "37835-641-01", "marketing_start_date": "20250201"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "37835-641_38f71fd9-448b-95d3-e063-6294a90a3523", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "37835-641", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Bi-Mart", "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": "20250201", "listing_expiration_date": "20261231"}