diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: time-cap labs, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler time-cap labs, inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Time-Cap Labs, Inc

Identifiers & Regulatory

Product NDC 49483-329
Product ID 49483-329_7d3b9a35-9e04-4289-e053-2a91aa0a5042
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2010-03-01

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 49483329
Hyphenated Format 49483-329

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 part341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100000 TABLET, COATED in 1 CARTON (49483-329-00)
source: ndc

Packages (1)

49483-329-00 100000 TABLET, COATED in 1 CARTON (49483-329-00)

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": "7d3b9a35-9e04-4289-e053-2a91aa0a5042", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["ed899055-0cbb-45bd-92c8-cbef2fc7c361"], "manufacturer_name": ["Time-Cap Labs, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100000 TABLET, COATED in 1 CARTON (49483-329-00)", "package_ndc": "49483-329-00", "marketing_start_date": "20181217"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "49483-329_7d3b9a35-9e04-4289-e053-2a91aa0a5042", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49483-329", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Time-Cap Labs, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DIPHENHYDRAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20100301", "listing_expiration_date": "20261231"}