Children'S Zyrtec Allergy, Children'S Zyrtec Hives Relief

NDA 21621, held by Kenvue Brands. Cetirizine Hydrochloride.

As of Nov 14, 2026, NDA 21621 (Children'S Zyrtec Allergy, Children'S Zyrtec Hives Relief), held by Kenvue Brands, was first approved by FDA on Mar 16, 2004, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2004
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Nov 16, 2007	Supplement 5Efficacy (new indication or use)	Approved	Review Letter
Mar 16, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter

Products

5 strengths and forms


Children'S Zyrtec Allergy5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Cetirizine Hydrochloride	DiscontinuedReference drug
Children'S Zyrtec Allergy10MG · tablet, chewable;oral	Cetirizine Hydrochloride	OTCReference drug
Children'S Zyrtec Hives Relief5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Cetirizine Hydrochloride	DiscontinuedReference drug
Children'S Zyrtec Hives Relief10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Cetirizine Hydrochloride	DiscontinuedReference drug
Children'S Zyrtec Allergy2.5MG · tablet, chewable;oral	Cetirizine Hydrochloride	OTCReference drug

All 7 submissions, including labeling and manufacturing supplements


Sep 28, 2026	Supplement 19Manufacturing	Approved	Letter Label
Mar 24, 2026	Supplement 18Labeling · Standard review	Approved	Label Letter
Aug 15, 2024	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 14, 2021	Supplement 12Labeling · Standard review	Approved	Letter Label
Nov 30, 2020	Supplement 10Manufacturing · Standard review	Approved	Label Letter
Nov 16, 2007	Supplement 5Efficacy (new indication or use)	Approved	Review Letter
Mar 16, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter

Identifiers

Application: NDA 21621
Drugs@FDA: Overview at FDA
Company: Kenvue Brands

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters