OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

ZYRTEC-D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride · Tablet, Film Coated, Extended Release

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ZYRTEC-D
Generic name
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Kenvue Brands LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
5
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cetirizine Hydrochloride 5 mg/1 1014678 View
Pseudoephedrine Hydrochloride 120 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha-Agonists [MoA] MoA All 85 members
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members
alpha-Adrenergic Agonist [EPC] EPC All 85 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021150
Application type
NDA · New Drug Application
Approval date
August 10, 2001
Sponsor
KENVUE BRANDS
Products on application
1
Submissions recorded
12
Products approved under application 021150.
Product Trade name Form Strength Ingredient Status TE Flags
021150-002 ZYRTEC-D 12 HOUR TABLET, EXTENDED RELEASE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021150.
Type No. Action Status Date Review
Supplement 25 Labeling Approved July 2, 2026 Standard
Supplement 22 Labeling Approved September 12, 2024 Standard
Supplement 21 Labeling Approved November 3, 2021 Standard
Supplement 13 Manufacturing (CMC) Approved March 9, 2016 Standard
Supplement 12 Manufacturing (CMC) Approved August 3, 2015 Standard
Supplement 11 Manufacturing (CMC) Approved February 12, 2014 Standard
Supplement 10 Manufacturing (CMC) Approved October 23, 2013 Standard
Supplement 7 Efficacy Approved November 9, 2007 Unknown
Supplement 5 Labeling Approved March 17, 2004 Standard
Supplement 2 Efficacy Approved April 14, 2003 Standard
Supplement 1 Manufacturing (CMC) Approved February 14, 2002 Standard
Original application 1 Type 4 - New Combination Approved August 10, 2001 Standard

Review documents

  • 0 · Supplement · July 6, 2026
  • 0 · Supplement · July 6, 2026
  • 0 · Supplement · September 16, 2024
  • 0 · Supplement · September 16, 2024
  • 0 · Supplement · November 16, 2021
  • 0 · Supplement · November 5, 2021
  • 0 · Supplement · May 21, 2008
  • 0 · Supplement · November 13, 2007
  • 0 · Supplement · April 5, 2004
  • 0 · Supplement · March 24, 2004
  • 0 · Supplement · May 29, 2003
  • 0 · Supplement · April 17, 2003
  • 0 · Original application · August 10, 2001
  • 0 · Original application · August 10, 2001
  • 0 · Original application · August 10, 2001

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260406). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260406

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Active ingredients (in each extended release tablet) Purpose Cetirizine HCl 5 mg Antihistamine Pseudoephedrine HCl 120 mg Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended release tablet) Purpose Cetirizine HCl 5 mg Antihistamine Pseudoephedrine HCl 120 mg Nasal decongestant

Adverse event reports

Source: openFDA FAERS
166,303
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CETIRIZINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50580-719-12 50580-719 Kenvue Brands LLC 2 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK February 28, 2023
50580-719-24 50580-719 Kenvue Brands LLC 4 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK February 28, 2023
50580-728-12 50580-728 Kenvue Brands LLC 2 BLISTER PACK in 1 CARTON (50580-728-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK January 1, 2008
50580-728-24 50580-728 Kenvue Brands LLC 4 BLISTER PACK in 1 CARTON (50580-728-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK January 1, 2008
50580-728-25 50580-728 Kenvue Brands LLC 4 BLISTER PACK in 1 CARTON (50580-728-25) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK January 1, 2008
50580-719 50580-719 Kenvue Brands LLC — February 28, 2023
50580-728 50580-728 Kenvue Brands LLC — January 1, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.