allergy relief

Generic: diphenhydramine hydrochloride

Labeler: fsa store inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy relief
Generic Name diphenhydramine hydrochloride
Labeler fsa store inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
FSA STORE INC.

Identifiers & Regulatory

Product NDC 81522-109
Product ID 81522-109_24999d88-1a63-7029-e063-6394a90ad4a9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-01-11

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 81522109
Hyphenated Format 81522-109

Supplemental Identifiers

RxCUI
1049630
UPC
0099581911973
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
  • 1 BOTTLE, PLASTIC in 1 CARTON (81522-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

81522-109-03 1 BOTTLE, PLASTIC in 1 CARTON (81522-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

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": "24999d88-1a63-7029-e063-6394a90ad4a9", "openfda": {"upc": ["0099581911973"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["ec6aef90-ece1-4fe6-e053-2995a90a9310"], "manufacturer_name": ["FSA STORE INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (81522-109-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "81522-109-03", "marketing_start_date": "20230111"}], "brand_name": "Allergy Relief", "product_id": "81522-109_24999d88-1a63-7029-e063-6394a90ad4a9", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "81522-109", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "FSA STORE 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": "20230111", "listing_expiration_date": "20261231"}