zyrtec allergy

Generic: cetirizine hydrochloride

Labeler: morning star otc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyrtec allergy
Generic Name cetirizine hydrochloride
Labeler morning star otc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Morning Star OTC

Identifiers & Regulatory

Product NDC 53209-5001
Product ID 53209-5001_37e96646-1587-1156-e063-6394a90a6b22
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019835
Listing Expiration 2026-12-31
Marketing Start 2025-06-19

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 532095001
Hyphenated Format 53209-5001

Supplemental Identifiers

RxCUI
1014678 1020026
UNII
64O047KTOA

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 zyrtec allergy (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA019835 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 TABLET, FILM COATED in 1 BLISTER PACK (53209-5001-1)
source: ndc

Packages (1)

53209-5001-1 1 TABLET, FILM COATED in 1 BLISTER PACK (53209-5001-1)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Zyrtec Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37e96646-1587-1156-e063-6394a90a6b22", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678", "1020026"], "spl_set_id": ["3efa421d-ea70-4b1f-95d0-7c63b6c39580"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 BLISTER PACK (53209-5001-1)", "package_ndc": "53209-5001-1", "marketing_start_date": "20250619"}], "brand_name": "Zyrtec Allergy", "product_id": "53209-5001_37e96646-1587-1156-e063-6394a90a6b22", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53209-5001", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Morning Star OTC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zyrtec Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA019835", "marketing_category": "NDA", "marketing_start_date": "20250619", "listing_expiration_date": "20261231"}