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Cetirizine HCl

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
Cetirizine HCl
Generic name
Cetirizine HCl
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
TOP CARE (Topco Associates LLC)
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
18
Packages
27
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

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
45

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
022429
Application type
NDA · New Drug Application
Approval date
July 23, 2009
Sponsor
BIONPHARMA
Products on application
4
Submissions recorded
6
Products approved under application 022429.
Product Trade name Form Strength Ingredient Status TE Flags
022429-001 CETIRIZINE HYDROCHLORIDE ALLERGY CAPSULE CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD
022429-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CAPSULE CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD RS
022429-003 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CAPSULE CETIRIZINE HYDROCHLORIDE Over-the-counter — RLD
022429-004 CETIRIZINE HYDROCHLORIDE ALLERGY CAPSULE CETIRIZINE 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 022429.
Type No. Action Status Date Review
Supplement 26 Labeling Approved January 30, 2026 Standard
Supplement 17 Labeling Approved December 7, 2020 Standard
Supplement 14 Manufacturing (CMC) Approved December 13, 2019 N/A
Supplement 9 Labeling Approved February 6, 2013 Standard
Supplement 3 Manufacturing (CMC) Approved April 6, 2010 Standard
Original application 1 Type 3 - New Dosage Form Approved July 23, 2009 Standard

Review documents

  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · February 3, 2026
  • 0 · Supplement · December 9, 2020
  • 0 · Supplement · April 14, 2020
  • 0 · Supplement · April 14, 2020
  • 0 · Supplement · January 14, 2014
  • 0 · Supplement · February 7, 2013
  • 0 · Supplement · April 8, 2010
  • 0 · Original application · December 16, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260511). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260511

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 one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor 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 alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. 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.

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 capsule) 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
46122-613-63 46122-613 AMERISOURCE BERGEN 1 BOTTLE, PLASTIC in 1 CARTON (46122-613-63) / 25 CAPSULE in 1 BOTTLE, PLASTIC June 18, 2019
46122-815-64 46122-815 AMERISOURCE BERGEN 1 BOTTLE, PLASTIC in 1 CARTON (46122-815-64) / 25 CAPSULE in 1 BOTTLE, PLASTIC May 30, 2026
69452-265-15 69452-265 Bionpharma Inc. 1 BOTTLE, PLASTIC in 1 CARTON (69452-265-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC May 1, 2019
69452-265-86 69452-265 Bionpharma Inc. 1 BOTTLE, PLASTIC in 1 CARTON (69452-265-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC May 1, 2019
69452-265-88 69452-265 Bionpharma Inc. 1 BOTTLE, PLASTIC in 1 CARTON (69452-265-88) / 65 CAPSULE in 1 BOTTLE, PLASTIC May 1, 2019
69452-479-88 69452-479 Bionpharma Inc. 1 BOTTLE, PLASTIC in 1 CARTON (69452-479-88) / 65 CAPSULE in 1 BOTTLE, PLASTIC May 25, 2026
51316-900-19 51316-900 CVS Pharmacy 1 BOTTLE, PLASTIC in 1 CARTON (51316-900-19) / 90 CAPSULE in 1 BOTTLE, PLASTIC August 24, 2026
55910-784-15 55910-784 DOLGENCORP INC 1 BOTTLE, PLASTIC in 1 CARTON (55910-784-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC November 25, 2024
55910-784-86 55910-784 DOLGENCORP INC 1 BOTTLE, PLASTIC in 1 CARTON (55910-784-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC November 25, 2024
30142-995-25 30142-995 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (30142-995-25) / 25 CAPSULE in 1 BOTTLE, PLASTIC June 3, 2019
30142-995-40 30142-995 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (30142-995-40) / 40 CAPSULE in 1 BOTTLE, PLASTIC June 3, 2019
30142-995-50 30142-995 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (30142-995-50) / 50 CAPSULE in 1 BOTTLE, PLASTIC June 3, 2019
59450-020-15 59450-020 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (59450-020-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC May 25, 2026
59450-020-86 59450-020 KROGER COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (59450-020-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC May 25, 2026
79481-0670-2 79481-0670 Meijer Distribution Inc 1 BOTTLE, PLASTIC in 1 PACKAGE (79481-0670-2) / 25 CAPSULE in 1 BOTTLE, PLASTIC November 25, 2024
79481-0671-2 79481-0671 Meijer Distribution Inc 1 BOTTLE, PLASTIC in 1 CARTON (79481-0671-2) / 25 CAPSULE in 1 BOTTLE, PLASTIC May 1, 2026
80136-856-23 80136-856 Northeast Pharma 1 BOTTLE, PLASTIC in 1 CARTON (80136-856-23) / 25 CAPSULE in 1 BOTTLE, PLASTIC September 26, 2023
56062-452-86 56062-452 PUBLIX SUPER MARKETS INC 1 BOTTLE, PLASTIC in 1 CARTON (56062-452-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC October 4, 2024
56062-495-86 56062-495 PUBLIX SUPER MARKETS INC 1 BOTTLE, PLASTIC in 1 CARTON (56062-495-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC July 15, 2026
11673-242-15 11673-242 TARGET Corporation 1 BOTTLE in 1 POUCH (11673-242-15) / 40 CAPSULE in 1 BOTTLE October 30, 2019
11673-650-15 11673-650 TARGET Corporation 1 BOTTLE in 1 CARTON (11673-650-15) / 40 CAPSULE in 1 BOTTLE December 9, 2025
36800-542-15 36800-542 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC November 22, 2024
36800-542-86 36800-542 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC November 22, 2024
36800-543-15 36800-543 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 CARTON (36800-543-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC May 30, 2026
36800-543-86 36800-543 TOP CARE (Topco Associates LLC) 1 BOTTLE, PLASTIC in 1 CARTON (36800-543-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC May 30, 2026
0363-6341-15 0363-6341 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-6341-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC May 25, 2026
0363-6341-78 0363-6341 WALGREEN COMPANY 1 BOTTLE, PLASTIC in 1 CARTON (0363-6341-78) / 80 CAPSULE in 1 BOTTLE, PLASTIC May 25, 2026
46122-613 46122-613 AMERISOURCE BERGEN — June 18, 2019
46122-815 46122-815 AMERISOURCE BERGEN — May 30, 2026
69452-265 69452-265 Bionpharma Inc. — May 1, 2019
69452-479 69452-479 Bionpharma Inc. — May 25, 2026
51316-900 51316-900 CVS Pharmacy — August 24, 2026
55910-784 55910-784 DOLGENCORP INC — November 25, 2024
30142-995 30142-995 KROGER COMPANY — June 3, 2019
59450-020 59450-020 KROGER COMPANY — May 25, 2026
79481-0670 79481-0670 Meijer Distribution Inc — November 25, 2024
79481-0671 79481-0671 Meijer Distribution Inc — May 1, 2026
80136-856 80136-856 Northeast Pharma — September 26, 2023
56062-452 56062-452 PUBLIX SUPER MARKETS INC — October 4, 2024
56062-495 56062-495 PUBLIX SUPER MARKETS INC — July 15, 2026
11673-242 11673-242 TARGET Corporation — October 30, 2019
11673-650 11673-650 TARGET Corporation — December 9, 2025
36800-542 36800-542 TOP CARE (Topco Associates LLC) — November 22, 2024
36800-543 36800-543 TOP CARE (Topco Associates LLC) — May 30, 2026
0363-6341 0363-6341 WALGREEN COMPANY — May 25, 2026

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 · 12 sections on this page.