Cetirizine — Tablet, Film Coated

Overview

Brand name

Cetirizine

Generic name

Cetirizine Hydrochloride

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Major Pharmaceuticals

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

9

Packages

22

Data completeness

83% 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

Tablet, Film Coated

Route of administration

Oral

Presentations

31

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@FDA NDC Directory

Application number

078336

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 27, 2007

Sponsor

PERRIGO R AND D

Products on application

4

Submissions recorded

2

Products approved under application 078336.
Product	Trade name	Form	Ingredient	Status	TE
078336-001	CETIRIZINE HYDROCHLORIDE ALLERGY	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
078336-002	CETIRIZINE HYDROCHLORIDE ALLERGY	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
078336-003	CETIRIZINE HYDROCHLORIDE HIVES	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—
078336-004	CETIRIZINE HYDROCHLORIDE HIVES	TABLET	CETIRIZINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 078336.
Type	No.	Action	Status	Date	Review
Supplement	10	Labeling	Approved	May 27, 2010	—
Original application	1		Approved	December 27, 2007	—

Review documents

0 · Original application · January 9, 2008
0 · Original application · January 8, 2008

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260319). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260319 HUMAN OTC DRUG · 20260101 HUMAN OTC DRUG · 20251030

Recent Major Changes

openFDA Drug Labeling

CETIRIZINE HCL 10MG Tabs

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 tablet once daily; do not take more than one 10 mg tablet 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 • 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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Cetirizine HCl 10 mg NDC: 72162-2162-2: 300 Tablets in a Bottle NDC: 72162-2162-5: 500 Tablets in a Bottle Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

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.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class III	November 17, 2021	A-S Medication Solutions LLC.	Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.	Terminated

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
50090-5510-1	50090-5510	A-S Medication Solutions	1 BOTTLE in 1 CARTON (50090-5510-1) / 30 TABLET, FILM COATED in 1 BOTTLE	April 12, 2021
50090-5510-3	50090-5510	A-S Medication Solutions	1 BOTTLE in 1 CARTON (50090-5510-3) / 90 TABLET, FILM COATED in 1 BOTTLE	April 12, 2021
50090-7594-0	50090-7594	A-S Medication Solutions	1 BOTTLE in 1 CARTON (50090-7594-0) / 30 TABLET, FILM COATED in 1 BOTTLE	July 3, 2025
50090-7594-1	50090-7594	A-S Medication Solutions	1 BOTTLE in 1 CARTON (50090-7594-1) / 90 TABLET, FILM COATED in 1 BOTTLE	July 3, 2025
71610-123-60	71610-123	Aphena Pharma Solutions - Tennessee, LLC	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-123-60)	August 17, 2018
72162-2162-2	72162-2162	Bryant Ranch Prepack	300 TABLET, FILM COATED in 1 BOTTLE (72162-2162-2)	July 3, 2018
72162-2162-5	72162-2162	Bryant Ranch Prepack	500 TABLET, FILM COATED in 1 BOTTLE (72162-2162-5)	July 3, 2018
55154-0194-0	55154-0194	Cardinal Health 107, LLC	10 BLISTER PACK in 1 BAG (55154-0194-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	November 7, 2025
0904-6717-40	0904-6717	Major Pharmaceuticals	500 TABLET, FILM COATED in 1 BOTTLE (0904-6717-40)	July 3, 2018
0904-6717-41	0904-6717	Major Pharmaceuticals	14 BLISTER PACK in 1 CARTON (0904-6717-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK	June 29, 2018
0904-6717-43	0904-6717	Major Pharmaceuticals	1 BOTTLE in 1 CARTON (0904-6717-43) / 45 TABLET, FILM COATED in 1 BOTTLE	July 3, 2018
0904-6717-46	0904-6717	Major Pharmaceuticals	1 BOTTLE in 1 CARTON (0904-6717-46) / 30 TABLET, FILM COATED in 1 BOTTLE	July 3, 2018
0904-6717-60	0904-6717	Major Pharmaceuticals	1 BOTTLE in 1 CARTON (0904-6717-60) / 100 TABLET, FILM COATED in 1 BOTTLE	July 3, 2018
0904-6717-72	0904-6717	Major Pharmaceuticals	1 BOTTLE in 1 CARTON (0904-6717-72) / 300 TABLET, FILM COATED in 1 BOTTLE	July 3, 2018
0904-6717-86	0904-6717	Major Pharmaceuticals	1 BOTTLE in 1 CARTON (0904-6717-86) / 90 TABLET, FILM COATED in 1 BOTTLE	July 3, 2018
0904-7510-61	0904-7510	Major Pharmaceuticals	100 BLISTER PACK in 1 CARTON (0904-7510-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	April 7, 2025
51655-194-26	51655-194	Northwind Health Company, LLC	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-26)	November 15, 2022
51655-194-52	51655-194	Northwind Health Company, LLC	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-52)	March 2, 2023
51655-194-60	51655-194	Northwind Health Company, LLC	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-60)	October 18, 2022
83939-0003-0	83939-0003	VERITYRX, LLC	50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-0) / 1 TABLET, FILM COATED in 1 POUCH	November 3, 2025
83939-0003-2	83939-0003	VERITYRX, LLC	50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-2) / 1 TABLET, FILM COATED in 1 POUCH	November 3, 2025
83939-0003-3	83939-0003	VERITYRX, LLC	100 POUCH in 1 BOX, UNIT-DOSE (83939-0003-3) / 1 TABLET, FILM COATED in 1 POUCH	November 3, 2025
50090-5510	50090-5510	A-S Medication Solutions	—	June 29, 2018
50090-7594	50090-7594	A-S Medication Solutions	—	June 29, 2018
71610-123	71610-123	Aphena Pharma Solutions - Tennessee, LLC	—	June 29, 2018
72162-2162	72162-2162	Bryant Ranch Prepack	—	June 29, 2018
55154-0194	55154-0194	Cardinal Health 107, LLC	—	November 7, 2025
0904-6717	0904-6717	Major Pharmaceuticals	—	June 29, 2018
0904-7510	0904-7510	Major Pharmaceuticals	—	April 7, 2025
51655-194	51655-194	Northwind Health Company, LLC	—	October 18, 2022
83939-0003	83939-0003	VERITYRX, LLC	—	November 3, 2025

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
Enforcement	FDA	Recall records

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