Zyrtec-D 12 Hour

NDA 21150, held by Kenvue Brands. Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride.

As of Nov 15, 2026, NDA 21150 (Zyrtec-D 12 Hour), held by Kenvue Brands, was first approved by FDA on Aug 10, 2001, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 10, 2001
Review: Standard
Supplements approved: 11
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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Nov 9, 2007	Supplement 7Efficacy (new indication or use)	Approved	Review Letter
Apr 14, 2003	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 10, 2001	Original applicationNew combination · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zyrtec-D 12 Hour5MG;120MG · tablet, extended release;oral	Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride	OTCReference drug

All 12 submissions, including labeling and manufacturing supplements


Jul 2, 2026	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 12, 2024	Supplement 22Labeling · Standard review	Approved	Letter Label
Nov 3, 2021	Supplement 21Labeling · Standard review	Approved	Label Letter
Mar 9, 2016	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 3, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 12, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 23, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 9, 2007	Supplement 7Efficacy (new indication or use)	Approved	Review Letter
Mar 17, 2004	Supplement 5Labeling · Standard review	Approved	Label Letter
Apr 14, 2003	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 14, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 10, 2001	Original applicationNew combination · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 21150
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