allergy relief

Generic: diphenhydramine hydrochloride

Labeler: time cap laboratories, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief
Generic Name diphenhydramine hydrochloride
Labeler time cap laboratories, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-061
Product ID 49483-061_385f6471-a79e-0c48-e063-6294a90af1a3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-05-01

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 49483061
Hyphenated Format 49483-061

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 allergy relief (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, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-10)
  • 1 BOTTLE in 1 CARTON (49483-061-42) / 24 TABLET, FILM COATED in 1 BOTTLE
  • 650 TABLET, FILM COATED in 1 BOTTLE (49483-061-62)
  • 365 TABLET, FILM COATED in 1 BOTTLE (49483-061-65)
source: ndc

Packages (5)

49483-061-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-01) 49483-061-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-10) 49483-061-42 1 BOTTLE in 1 CARTON (49483-061-42) / 24 TABLET, FILM COATED in 1 BOTTLE 49483-061-62 650 TABLET, FILM COATED in 1 BOTTLE (49483-061-62) 49483-061-65 365 TABLET, FILM COATED in 1 BOTTLE (49483-061-65)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

ALLERGY RELIEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "385f6471-a79e-0c48-e063-6294a90af1a3", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["7aee34b5-1583-4a8a-8ffb-b17ef2722ac1"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-01)", "package_ndc": "49483-061-01", "marketing_start_date": "20181217"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-061-10)", "package_ndc": "49483-061-10", "marketing_start_date": "20181217"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (49483-061-42)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "49483-061-42", "marketing_start_date": "20210730"}, {"sample": false, "description": "650 TABLET, FILM COATED in 1 BOTTLE (49483-061-62)", "package_ndc": "49483-061-62", "marketing_start_date": "20120501"}, {"sample": false, "description": "365 TABLET, FILM COATED in 1 BOTTLE (49483-061-65)", "package_ndc": "49483-061-65", "marketing_start_date": "20220221"}], "brand_name": "ALLERGY RELIEF", "product_id": "49483-061_385f6471-a79e-0c48-e063-6294a90af1a3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49483-061", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ALLERGY RELIEF", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120501", "listing_expiration_date": "20261231"}