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Cetirizine Hydrochloride

Over-the-counter 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
Tablet, Orally Disintegrating
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
7
Packages
10
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
Tablet, Orally Disintegrating
Route of administration
Oral
Presentations
17

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
213557
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 11, 2020
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
1
Products approved under application 213557.
Product Trade name Form Strength Ingredient Status TE Flags
213557-001 CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 213557.
Type No. Action Status Date Review
Original application 1 Approved September 11, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20210506). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20210506

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 Tablet melts in mouth. Can be taken with or without water. 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

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

Drug Facts Active ingredient (in each tablet) Cetirizine hydrochloride 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
58602-838-14 58602-838 Aurohealth LLC 11 BLISTER PACK in 1 CARTON (58602-838-14) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) September 11, 2020
58602-838-19 58602-838 Aurohealth LLC 20 BLISTER PACK in 1 CARTON (58602-838-19) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) January 28, 2025
58602-838-75 58602-838 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-838-75) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) September 11, 2020
58602-838-76 58602-838 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-838-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (58602-838-74) September 11, 2020
58602-860-76 58602-860 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-860-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK February 12, 2021
58602-862-76 58602-862 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-862-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK February 18, 2021
69842-234-76 69842-234 CVS Pharmacy, Inc. 4 BLISTER PACK in 1 CARTON (69842-234-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK September 11, 2020
30142-058-76 30142-058 KROGER COMPANY 4 BLISTER PACK in 1 CARTON (30142-058-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK March 8, 2021
76162-009-76 76162-009 TOPCO ASSOCIATES LLC 4 BLISTER PACK in 1 CARTON (76162-009-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK June 6, 2024
0363-0471-76 0363-0471 WALGREEN CO. 4 BLISTER PACK in 1 CARTON (0363-0471-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK September 11, 2020
58602-838 58602-838 Aurohealth LLC — September 11, 2020
58602-860 58602-860 Aurohealth LLC — February 12, 2021
58602-862 58602-862 Aurohealth LLC — February 18, 2021
69842-234 69842-234 CVS Pharmacy, Inc. — September 11, 2020
30142-058 30142-058 KROGER COMPANY — March 8, 2021
76162-009 76162-009 TOPCO ASSOCIATES LLC — June 6, 2024
0363-0471 0363-0471 WALGREEN CO. — September 11, 2020

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.