zyrtec allergy

Generic: cetirizine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyrtec allergy
Generic Name cetirizine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-754
Product ID 50580-754_3a6e2ec1-eab8-beec-e063-6394a90aa39c
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019835
Listing Expiration 2026-12-31
Marketing Start 2025-02-15

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 50580754
Hyphenated Format 50580-754

Supplemental Identifiers

RxCUI
1014676 1014677
UPC
0300450256157
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 zyrtec allergy (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA019835 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 POUCH in 1 CARTON (50580-754-15) / 1 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

50580-754-15 15 POUCH in 1 CARTON (50580-754-15) / 1 TABLET, FILM COATED in 1 POUCH 50580-754-35 1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 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": "3a6e2ec1-eab8-beec-e063-6394a90aa39c", "openfda": {"upc": ["0300450256157"], "unii": ["64O047KTOA"], "rxcui": ["1014676", "1014677"], "spl_set_id": ["2c1ecee3-c2c1-25a2-e063-6294a90aad54"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 POUCH in 1 CARTON (50580-754-15)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50580-754-15", "marketing_start_date": "20250215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-754-35)  / 35 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-754-35", "marketing_start_date": "20250215"}], "brand_name": "Zyrtec Allergy", "product_id": "50580-754_3a6e2ec1-eab8-beec-e063-6394a90aa39c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-754", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Zyrtec Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA019835", "marketing_category": "NDA", "marketing_start_date": "20250215", "listing_expiration_date": "20261231"}