zyrtec hives

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-116
Product ID 50580-116_37b38291-50c9-00c9-e063-6394a90a83ef
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019835
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

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 50580116
Hyphenated Format 50580-116

Supplemental Identifiers

RxCUI
1014678 1020026
UPC
0300450138323
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 hives (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 BOTTLE in 1 CARTON (50580-116-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

50580-116-30 1 BOTTLE in 1 CARTON (50580-116-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

ZYRTEC Hives ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37b38291-50c9-00c9-e063-6394a90a83ef", "openfda": {"upc": ["0300450138323"], "unii": ["64O047KTOA"], "rxcui": ["1014678", "1020026"], "spl_set_id": ["31136e3a-94fa-0860-e063-6394a90a008d"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-116-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-116-30", "marketing_start_date": "20250602"}], "brand_name": "ZYRTEC Hives", "product_id": "50580-116_37b38291-50c9-00c9-e063-6394a90a83ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-116", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ZYRTEC Hives", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA019835", "marketing_category": "NDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}