childrens zyrtec

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-791
Product ID 50580-791_323f0be7-9566-00a5-e063-6394a90a4b0d
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021621
Listing Expiration 2026-12-31
Marketing Start 2021-06-21

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 50580791
Hyphenated Format 50580-791

Supplemental Identifiers

RxCUI
1014674 1020022
UPC
0300450241245
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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA021621 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (50580-791-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
  • 8 BLISTER PACK in 1 CARTON (50580-791-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50580-791-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (50580-791-72) / 24 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (4)

50580-791-01 4 BLISTER PACK in 1 CARTON (50580-791-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 50580-791-02 8 BLISTER PACK in 1 CARTON (50580-791-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 50580-791-03 1 BLISTER PACK in 1 CARTON (50580-791-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 50580-791-72 3 BLISTER PACK in 1 CARTON (50580-791-72) / 24 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Childrens Zyrtec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "323f0be7-9566-00a5-e063-6394a90a4b0d", "openfda": {"upc": ["0300450241245"], "unii": ["64O047KTOA"], "rxcui": ["1014674", "1020022"], "spl_set_id": ["0fe77356-d945-46a0-882e-b3bbab784556"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-791-01)  / 6 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "50580-791-01", "marketing_start_date": "20210621"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (50580-791-02)  / 6 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "50580-791-02", "marketing_start_date": "20230101"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-791-03)  / 6 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "50580-791-03", "marketing_start_date": "20220901"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50580-791-72)  / 24 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "50580-791-72", "marketing_start_date": "20240115"}], "brand_name": "Childrens Zyrtec", "product_id": "50580-791_323f0be7-9566-00a5-e063-6394a90a4b0d", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-791", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Zyrtec", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA021621", "marketing_category": "NDA", "marketing_start_date": "20210621", "listing_expiration_date": "20261231"}