childrens zyrtec allergy

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens zyrtec allergy
Generic Name cetirizine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-782
Product ID 50580-782_327f7ae1-8b12-ef7a-e063-6294a90abd4a
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022578
Listing Expiration 2026-12-31
Marketing Start 2014-01-20

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 50580782
Hyphenated Format 50580-782

Supplemental Identifiers

RxCUI
1011482 1011485
UPC
0300450242136
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 childrens zyrtec allergy (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA022578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-782-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50580-782-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (3)

50580-782-01 2 CARTON in 1 PACKAGE (50580-782-01) / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 50580-782-12 2 BLISTER PACK in 1 CARTON (50580-782-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 50580-782-24 4 BLISTER PACK in 1 CARTON (50580-782-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Childrens Zyrtec Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "327f7ae1-8b12-ef7a-e063-6294a90abd4a", "openfda": {"upc": ["0300450242136"], "unii": ["64O047KTOA"], "rxcui": ["1011482", "1011485"], "spl_set_id": ["a1edc2e6-3661-4d7a-884c-709d73cb89e0"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-782-01)  / 4 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50580-782-01", "marketing_start_date": "20140120"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-782-12)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50580-782-12", "marketing_start_date": "20140120"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-782-24)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50580-782-24", "marketing_start_date": "20140120"}], "brand_name": "Childrens Zyrtec Allergy", "product_id": "50580-782_327f7ae1-8b12-ef7a-e063-6294a90abd4a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-782", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Zyrtec Allergy", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA022578", "marketing_category": "NDA", "marketing_start_date": "20140120", "listing_expiration_date": "20261231"}