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CETIRIZINE HYDROCHLORIDE

ANDA 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 hydrochloride
Generic name
Cetirizine Hydrochloride
Dosage form
Capsule, Liquid Filled
Route
—
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Patheon Softgels Inc.
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
9
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 350 mg/1 1014678 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Liquid Filled
Route of administration
—
Presentations
15

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
205291
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 21, 2017
Sponsor
ONESOURCE
Products on application
1
Submissions recorded
1
Products approved under application 205291.
Product Trade name Form Strength Ingredient Status TE Flags
205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY CAPSULE CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 205291.
Type No. Action Status Date Review
Original application 1 Approved July 21, 2017 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260824). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260824

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 avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness 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.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each capsule) Cetirizine HCl USP, 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
61474-4307-1 61474-4307 Catalent Ontario Limited 12000 CAPSULE, LIQUID FILLED in 1 CARTON (61474-4307-1) October 22, 2021
61474-4370-1 61474-4370 Catalent Ontario Limited 12000 CAPSULE, LIQUID FILLED in 1 CARTON (61474-4370-1) August 17, 2023
10888-8116-1 10888-8116 Patheon Softgels Inc. 15000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8116-1) January 1, 2018
10888-8120-1 10888-8120 Patheon Softgels Inc. 15000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8120-1) June 4, 2010
10888-8121-1 10888-8121 Patheon Softgels Inc. 15000 CAPSULE, LIQUID FILLED in 1 BOX (10888-8121-1) January 18, 2017
59556-894-12 59556-894 Strides Pharma, Inc. 1 BOTTLE in 1 CARTON (59556-894-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE July 21, 2017
59556-894-77 59556-894 Strides Pharma, Inc. 1 BOTTLE in 1 CARTON (59556-894-77) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE July 21, 2017
59556-894-78 59556-894 Strides Pharma, Inc. 1 BOTTLE in 1 CARTON (59556-894-78) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE July 21, 2017
59556-894-79 59556-894 Strides Pharma, Inc. 7000 CAPSULE, LIQUID FILLED in 1 BAG (59556-894-79) July 21, 2017
61474-4307 61474-4307 Catalent Ontario Limited — October 22, 2021
61474-4370 61474-4370 Catalent Ontario Limited — August 17, 2023
10888-8116 10888-8116 Patheon Softgels Inc. — July 23, 2009
10888-8120 10888-8120 Patheon Softgels Inc. — July 23, 2009
10888-8121 10888-8121 Patheon Softgels Inc. — July 23, 2009
59556-894 59556-894 Strides Pharma, Inc. — July 21, 2017

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.