allergy relief

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 10 mg/1

Manufacturer
FSA STORE INC.

Identifiers & Regulatory

Product NDC 81522-194
Product ID 81522-194_2fc20c71-6615-68d4-e063-6294a90a736e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
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 81522194
Hyphenated Format 81522-194

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

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 cetirizine hydrochloride (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (81522-194-04) / 45 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (81522-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

81522-194-04 1 BOTTLE, PLASTIC in 1 CARTON (81522-194-04) / 45 TABLET, COATED in 1 BOTTLE, PLASTIC 81522-194-16 1 BOTTLE, PLASTIC in 1 CARTON (81522-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

cetirizine hydrochloride (10 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": "2fc20c71-6615-68d4-e063-6294a90a736e", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["ec6b4e86-ac27-e1f2-e053-2a95a90ab3e1"], "manufacturer_name": ["FSA STORE INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (81522-194-04)  / 45 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "81522-194-04", "marketing_start_date": "20230111"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (81522-194-16)  / 90 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "81522-194-16", "marketing_start_date": "20250303"}], "brand_name": "Allergy Relief", "product_id": "81522-194_2fc20c71-6615-68d4-e063-6294a90a736e", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "81522-194", "generic_name": "Cetirizine hydrochloride", "labeler_name": "FSA STORE INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy Relief", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20230111", "listing_expiration_date": "20261231"}