Zyrtec Allergy, Zyrtec Hives

NDA 19835, held by Kenvue Brands. Cetirizine Hydrochloride.

As of Nov 13, 2026, NDA 19835 (Zyrtec Allergy, Zyrtec Hives), held by Kenvue Brands, was first approved by FDA on Dec 8, 1995, with 34 approved supplements and 0 published complete response letters.

First approved: Dec 8, 1995
Review: Standard
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses 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 35 submissions below

Date	Submission	Status	Documents
Nov 16, 2007	Supplement 22Efficacy (new indication or use)	Approved	Review Letter
Oct 21, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
May 15, 1998	Supplement 5Efficacy (new indication or use)	Approved	Letter Review
Dec 8, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Products

4 strengths and forms

Product	Active ingredient	Marketing
Zyrtec Allergy5MG · tablet;oral	Cetirizine Hydrochloride	OTCReference drug
Zyrtec Allergy10MG · tablet;oral	Cetirizine Hydrochloride	OTCReference drug
Zyrtec Hives5MG · tablet;oral	Cetirizine Hydrochloride	DiscontinuedReference drug
Zyrtec Hives10MG · tablet;oral	Cetirizine Hydrochloride	DiscontinuedReference drug

All 35 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 11, 2026	Supplement 55Labeling · Standard review	Approved	Label Letter
Apr 24, 2025	Supplement 53Labeling · Standard review	Approved	Label Letter
Mar 25, 2025	Supplement 52Labeling · Standard review	Approved	Letter Label
Nov 26, 2024	Supplement 50Labeling · Standard review	Approved	Letter Label
Mar 28, 2024	Supplement 47Manufacturing	Approved	Label Letter
Dec 1, 2023	Supplement 46Labeling · Standard review	Approved	Label Letter
May 8, 2023	Supplement 45Labeling · Standard review	Approved	Label Letter
Aug 7, 2019	Supplement 40Labeling · Standard review	Approved	Label Letter
Dec 8, 2017	Supplement 39Manufacturing	Approved	None posted
Apr 4, 2016	Supplement 36Manufacturing · Standard review	Approved	None posted
Jan 20, 2015	Supplement 35Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 10, 2012	Supplement 32Labeling · Standard review	Approved	Label Letter
Mar 13, 2012	Supplement 30Labeling · Standard review	Approved	Letter
Jan 26, 2012	Supplement 29Labeling · Standard review	Approved	Letter
Feb 26, 2010	Supplement 28Labeling	Approved	Letter
Feb 26, 2010	Supplement 26Labeling · Standard review	Approved	None posted
Nov 25, 2008	Supplement 25Manufacturing	Approved	Letter
Nov 16, 2007	Supplement 22Efficacy (new indication or use)	Approved	Review Letter
Apr 4, 2006	Supplement 20Manufacturing · Standard review	Approved	Letter
Mar 17, 2004	Supplement 16Labeling · Standard review	Approved	Review Label Letter
Oct 21, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 19, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 25, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Feb 4, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 1, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 9, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 27, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
May 22, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
May 15, 1998	Supplement 5Efficacy (new indication or use)	Approved	Letter Review
Nov 14, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 1, 1996	Supplement 4Labeling · Standard review	Approved	None posted
Sep 23, 1996	Supplement 2Labeling · Standard review	Approved	None posted
May 23, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 8, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 19835
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