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Cetirizine Hydrochloride (Allergy)

Cetirizine Hydrochloride · Capsule

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 (Allergy)
Generic name
Cetirizine Hydrochloride
Dosage form
Capsule
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
6
Packages
11
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
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
209107
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 20, 2018
Sponsor
AUROBINDO PHARMA LTD
Products on application
2
Submissions recorded
1
Products approved under application 209107.
Product Trade name Form Strength Ingredient Status TE Flags
209107-001 CETIRIZINE HYDROCHLORIDE ALLERGY CAPSULE CETIRIZINE HYDROCHLORIDE Over-the-counter —
209107-002 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CAPSULE CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209107.
Type No. Action Status Date Review
Original application 1 Approved July 20, 2018 Standard

Review documents

  • 0 · Original application · August 16, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20231122). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20231122

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

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 HCI 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
58602-716-16 58602-716 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-716-16) / 65 CAPSULE in 1 BOTTLE August 16, 2022
58602-806-04 58602-806 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-806-04) / 12 CAPSULE in 1 BOTTLE July 20, 2018
58602-806-12 58602-806 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-806-12) / 40 CAPSULE in 1 BOTTLE July 20, 2018
58602-806-16 58602-806 Aurohealth LLC 65 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLE July 20, 2018
58602-806-53 58602-806 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLE July 20, 2018
58602-863-12 58602-863 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-863-12) / 40 CAPSULE in 1 BOTTLE March 12, 2021
21130-099-97 21130-099 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-099-97) / 25 CAPSULE in 1 BOTTLE November 15, 2023
11822-4228-1 11822-4228 RITE AID CORPORATION 1 BOTTLE in 1 CARTON (11822-4228-1) / 25 CAPSULE in 1 BOTTLE June 24, 2022
11822-4228-2 11822-4228 RITE AID CORPORATION 1 BOTTLE in 1 CARTON (11822-4228-2) / 40 CAPSULE in 1 BOTTLE June 24, 2022
0363-0068-12 0363-0068 WALGREEN CO. 1 BOTTLE in 1 CARTON (0363-0068-12) / 40 CAPSULE in 1 BOTTLE June 8, 2020
0363-0068-53 0363-0068 WALGREEN CO. 1 BOTTLE in 1 CARTON (0363-0068-53) / 25 CAPSULE in 1 BOTTLE June 8, 2020
58602-716 58602-716 Aurohealth LLC — August 16, 2022
58602-806 58602-806 Aurohealth LLC — July 20, 2018
58602-863 58602-863 Aurohealth LLC — March 12, 2021
21130-099 21130-099 Better Living Brands, LLC — November 15, 2023
11822-4228 11822-4228 RITE AID CORPORATION — June 24, 2022
0363-0068 0363-0068 WALGREEN CO. — June 8, 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.