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Zyrtec Allergy

Cetirizine Hydrochloride · Tablet, Film Coated

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 Allergy
Generic name
Cetirizine Hydrochloride
Dosage form
Tablet, Film Coated
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
7
Packages
30
Data completeness
82% 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 10 mg/1 1014678 View
Cetirizine Hydrochloride 5 mg/1 1014678 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
37

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
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
019835
Application type
NDA · New Drug Application
Approval date
December 8, 1995
Sponsor
KENVUE BRANDS
Products on application
4
Submissions recorded
35
Products approved under application 019835.
Product Trade name Form Strength Ingredient Status TE Flags
019835-003 ZYRTEC ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD
019835-004 ZYRTEC ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD RS
019835-005 ZYRTEC HIVES TABLET CETIRIZINE HYDROCHLORIDE Discontinued — RLD
019835-006 ZYRTEC HIVES TABLET CETIRIZINE HYDROCHLORIDE Discontinued — RLD

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 019835.
Type No. Action Status Date Review
Supplement 55 Labeling Approved June 11, 2026 Standard
Supplement 53 Labeling Approved April 24, 2025 Standard
Supplement 52 Labeling Approved March 25, 2025 Standard
Supplement 50 Labeling Approved November 26, 2024 Standard
Supplement 47 Manufacturing (CMC) Approved March 28, 2024 N/A
Supplement 46 Labeling Approved December 1, 2023 Standard
Supplement 45 Labeling Approved May 8, 2023 Standard
Supplement 40 Labeling Approved August 7, 2019 Standard
Supplement 39 Manufacturing (CMC) Approved December 8, 2017 N/A
Supplement 36 Manufacturing (CMC) Approved April 4, 2016 Standard
Supplement 35 Manufacturing (CMC) Approved January 20, 2015 Standard
Supplement 34 Manufacturing (CMC) Approved September 26, 2014 Standard
Supplement 32 Labeling Approved September 10, 2012 Standard
Supplement 30 Labeling Approved March 13, 2012 Standard
Supplement 29 Labeling Approved January 26, 2012 Standard
Supplement 28 Labeling Approved February 26, 2010 Unknown
Supplement 26 Labeling Approved February 26, 2010 Standard
Supplement 25 Manufacturing (CMC) Approved November 25, 2008 N/A
Supplement 22 Efficacy Approved November 16, 2007 Unknown
Supplement 20 Manufacturing (CMC) Approved April 4, 2006 Standard
Supplement 16 Labeling Approved March 17, 2004 Standard
Supplement 15 Efficacy Approved October 21, 2002 Standard
Supplement 13 Manufacturing (CMC) Approved September 19, 2000 Standard
Supplement 10 Labeling Approved February 25, 2000 Standard
Supplement 9 Manufacturing (CMC) Approved February 4, 2000 Standard
Supplement 11 Manufacturing (CMC) Approved February 1, 2000 Standard
Supplement 8 Manufacturing (CMC) Approved July 9, 1999 Standard
Supplement 7 Manufacturing (CMC) Approved January 27, 1999 Standard
Supplement 6 Manufacturing (CMC) Approved May 22, 1998 Standard
Supplement 5 Efficacy Approved May 15, 1998 Unknown
Supplement 3 Manufacturing (CMC) Approved November 14, 1996 Standard
Supplement 4 Labeling Approved November 1, 1996 Standard
Supplement 2 Labeling Approved September 23, 1996 Standard
Supplement 1 Manufacturing (CMC) Approved May 23, 1996 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 8, 1995 Standard

Review documents

  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · June 16, 2026
  • 0 · Supplement · May 21, 2025
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · March 27, 2025
  • 0 · Supplement · March 27, 2025
  • 0 · Supplement · November 29, 2024
  • 0 · Supplement · November 29, 2024
  • 0 · Supplement · April 1, 2024
  • 0 · Supplement · April 1, 2024
  • 0 · Supplement · December 15, 2023
  • 0 · Supplement · December 5, 2023
  • 0 · Supplement · May 9, 2023
  • 0 · Supplement · May 9, 2023
  • 0 · Supplement · August 8, 2019
  • 0 · Supplement · August 8, 2019
  • 0 · Supplement · December 12, 2012
  • 0 · Supplement · September 11, 2012
  • 0 · Supplement · March 15, 2012
  • 0 · Supplement · January 30, 2012
  • 0 · Supplement · March 4, 2010
  • 0 · Supplement · January 12, 2009
  • 0 · Supplement · January 12, 2009
  • 0 · Supplement · November 28, 2008
  • 0 · Supplement · May 21, 2008
  • 0 · Supplement · November 26, 2007
  • 0 · Supplement · April 7, 2006
  • 0 · Supplement · April 5, 2004
  • 0 · Supplement · March 24, 2004
  • 0 · Supplement · October 21, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260713). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260713 HUMAN OTC DRUG · 20250721

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 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. Ask a doctor before use if you have 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 ■ 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. 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.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have 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.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Cetirizine HCl 10 mg

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
50580-726-03 50580-726 Kenvue Brands LLC 50 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK January 1, 2008
50580-726-05 50580-726 Kenvue Brands LLC 50 POUCH in 1 CARTON (50580-726-05) / 1 TABLET, FILM COATED in 1 POUCH March 1, 2023
50580-726-25 50580-726 Kenvue Brands LLC 2500 POUCH in 1 CASE (50580-726-25) / 1 TABLET, FILM COATED in 1 POUCH March 1, 2023
50580-726-36 50580-726 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC January 1, 2008
50580-726-40 50580-726 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC January 20, 2014
50580-726-45 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-726-45) / 45 TABLET, FILM COATED in 1 BOTTLE July 31, 2025
50580-726-50 50580-726 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC January 26, 2010
50580-726-66 50580-726 Kenvue Brands LLC 75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66) January 1, 2008
50580-726-70 50580-726 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC January 1, 2008
50580-726-71 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-726-71) / 30 TABLET, FILM COATED in 1 BOTTLE November 1, 2024
50580-726-72 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE November 1, 2024
50580-726-73 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-726-73) / 60 TABLET, FILM COATED in 1 BOTTLE November 1, 2024
50580-726-74 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-726-74) / 90 TABLET, FILM COATED in 1 BOTTLE November 1, 2024
50580-726-75 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-726-75) / 75 TABLET, FILM COATED in 1 BOTTLE July 31, 2025
50580-726-90 50580-726 Kenvue Brands LLC 2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC January 26, 2010
50580-726-91 50580-726 Kenvue Brands LLC 2500 POUCH in 1 CARTON (50580-726-91) / 1 TABLET, FILM COATED in 1 POUCH July 27, 2018
50580-726-92 50580-726 Kenvue Brands LLC 50 POUCH in 1 TRAY (50580-726-92) / 1 TABLET, FILM COATED in 1 POUCH July 12, 2018
50580-726-93 50580-726 Kenvue Brands LLC 3 POUCH in 1 CARTON (50580-726-93) / 1 TABLET, FILM COATED in 1 POUCH July 27, 2018
50580-726-94 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 PACKAGE (50580-726-94) / 60 TABLET, FILM COATED in 1 BOTTLE June 15, 2020
50580-726-95 50580-726 Kenvue Brands LLC 1 BOTTLE in 1 PACKAGE (50580-726-95) / 90 TABLET, FILM COATED in 1 BOTTLE June 15, 2020
50580-726-96 50580-726 Kenvue Brands LLC 5 POUCH in 1 CARTON (50580-726-96) / 1 TABLET, FILM COATED in 1 POUCH May 30, 2020
50580-726-97 50580-726 Kenvue Brands LLC 14 POUCH in 1 CARTON (50580-726-97) / 1 TABLET, FILM COATED in 1 POUCH May 30, 2020
50580-754-15 50580-754 Kenvue Brands LLC 15 POUCH in 1 CARTON (50580-754-15) / 1 TABLET, FILM COATED in 1 POUCH February 15, 2025
50580-754-35 50580-754 Kenvue Brands LLC 1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE February 15, 2025
53209-5001-1 53209-5001 Morning Star OTC 1 TABLET, FILM COATED in 1 BLISTER PACK (53209-5001-1) June 19, 2025
67751-192-01 67751-192 Navajo Manufacturing Company Incorporated 1 POUCH in 1 CARTON (67751-192-01) / 1 TABLET, FILM COATED in 1 POUCH November 20, 2019
67296-1484-3 67296-1484 RedPharm Drug Inc 30 TABLET, FILM COATED in 1 BOTTLE (67296-1484-3) January 1, 2008
73097-016-20 73097-016 Savings Distributors LLC 20 POUCH in 1 CARTON (73097-016-20) / 1 TABLET, FILM COATED in 1 POUCH June 1, 2026
85237-2960-1 85237-2960 Select Consumer Group 1 POUCH in 1 BLISTER PACK (85237-2960-1) / 1 TABLET, FILM COATED in 1 POUCH (85237-2960-0) January 1, 2008
85237-2960-3 85237-2960 Select Consumer Group 20 POUCH in 1 CARTON (85237-2960-3) / 1 TABLET, FILM COATED in 1 POUCH (85237-2960-0) January 1, 2008
50580-726 50580-726 Kenvue Brands LLC — January 1, 2008
50580-754 50580-754 Kenvue Brands LLC — February 15, 2025
53209-5001 53209-5001 Morning Star OTC — June 19, 2025
67751-192 67751-192 Navajo Manufacturing Company Incorporated — November 20, 2019
67296-1484 67296-1484 RedPharm Drug Inc — January 1, 2008
73097-016 73097-016 Savings Distributors LLC — June 1, 2026
85237-2960 85237-2960 Select Consumer Group — 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.