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Cetirizine Hydrochloride (Hives Relief)

Cetirizine Hydrochloride · Tablet

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 (Hives Relief)
Generic name
Cetirizine Hydrochloride
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
18
Data completeness
76% 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
Route of administration
Oral
Presentations
21

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
090760
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 5, 2015
Sponsor
AUROBINDO PHARMA LTD
Products on application
4
Submissions recorded
1
Products approved under application 090760.
Product Trade name Form Strength Ingredient Status TE Flags
090760-001 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
090760-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
090760-003 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
090760-004 CETIRIZINE HYDROCHLORIDE HIVES RELIEF TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 090760.
Type No. Action Status Date Review
Original application 1 Approved August 5, 2015 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260803). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260803

Indications and Usage

openFDA Drug Labeling

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions For 5 mg: adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: 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 Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 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. hives that are an unusual color, look bruised or blistered hives that do not itch

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment. the hives have lasted more than 6 weeks.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: 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
58602-446-09 58602-446 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-446-09) / 30 TABLET in 1 BOTTLE August 5, 2015
58602-446-17 58602-446 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-446-17) / 45 TABLET in 1 BOTTLE August 5, 2015
58602-446-21 58602-446 Aurohealth LLC 10 BLISTER PACK in 1 CARTON (58602-446-21) / 10 TABLET in 1 BLISTER PACK August 5, 2015
58602-446-41 58602-446 Aurohealth LLC 1000 TABLET in 1 BOTTLE (58602-446-41) August 5, 2015
58602-446-47 58602-446 Aurohealth LLC 75 TABLET in 1 PACKAGE, COMBINATION (58602-446-47) August 5, 2015
58602-447-09 58602-447 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-447-09) / 30 TABLET in 1 BOTTLE August 5, 2015
58602-447-17 58602-447 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-447-17) / 45 TABLET in 1 BOTTLE August 5, 2015
58602-447-21 58602-447 Aurohealth LLC 10 BLISTER PACK in 1 CARTON (58602-447-21) / 10 TABLET in 1 BLISTER PACK August 5, 2015
58602-447-41 58602-447 Aurohealth LLC 1000 TABLET in 1 BOTTLE (58602-447-41) August 5, 2015
58602-447-47 58602-447 Aurohealth LLC 75 TABLET in 1 PACKAGE, COMBINATION (58602-447-47) August 5, 2015
58602-813-04 58602-813 Aurohealth LLC 10 TABLET in 1 CARTON (58602-813-04) August 5, 2015
58602-813-09 58602-813 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-813-09) / 30 TABLET in 1 BOTTLE August 5, 2015
58602-813-17 58602-813 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-813-17) / 45 TABLET in 1 BOTTLE August 5, 2015
58602-813-23 58602-813 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-813-23) / 120 TABLET in 1 BOTTLE August 5, 2015
58602-813-39 58602-813 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-813-39) / 365 TABLET in 1 BOTTLE August 5, 2015
58602-813-41 58602-813 Aurohealth LLC 1000 TABLET in 1 BOTTLE (58602-813-41) August 5, 2015
58602-813-83 58602-813 Aurohealth LLC 10 TABLET in 1 BLISTER PACK (58602-813-83) August 5, 2015
58602-813-99 58602-813 Aurohealth LLC 75 TABLET in 1 PACKAGE, COMBINATION (58602-813-99) August 5, 2015
58602-446 58602-446 Aurohealth LLC — August 5, 2015
58602-447 58602-447 Aurohealth LLC — August 5, 2015
58602-813 58602-813 Aurohealth LLC — August 5, 2015

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 · 10 sections on this page.