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Cetirizine HCl

Cetirizine · 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 HCl
Generic name
Cetirizine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
GLENMARK THERAPEUTICS INC., USA
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
4
Packages
42
Data completeness
77% 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
46

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
078427
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 28, 2007
Sponsor
GLENMARK PHARMS
Products on application
2
Submissions recorded
2
Products approved under application 078427.
Product Trade name Form Strength Ingredient Status TE Flags
078427-003 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —
078427-004 CETIRIZINE HYDROCHLORIDE ALLERGY TABLET CETIRIZINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 078427.
Type No. Action Status Date Review
Supplement 6 Manufacturing (CMC) Approved April 3, 2025 Unknown
Original application 1 Approved December 28, 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 20260807). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260807 HUMAN OTC DRUG · 20251219

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 Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets, USP 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 Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine Ask a doctor before useif 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. 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)

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 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

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 II April 16, 2025 Glenmark Pharmaceuticals Inc., USA CGMP Deviations Ongoing

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
72657-128-03 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE May 13, 2024
72657-128-04 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE May 13, 2024
72657-128-08 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE May 13, 2024
72657-128-14 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE May 13, 2024
72657-128-15 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE May 13, 2024
72657-128-18 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE May 13, 2024
72657-128-24 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE May 13, 2024
72657-128-30 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE May 13, 2024
72657-128-35 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE May 13, 2024
72657-128-41 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE May 13, 2024
72657-128-45 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE May 13, 2024
72657-128-60 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE May 13, 2024
72657-128-70 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE May 13, 2024
72657-128-81 72657-128 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE May 13, 2024
72657-128-82 72657-128 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE May 13, 2024
72657-128-84 72657-128 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE May 13, 2024
72657-128-86 72657-128 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE May 13, 2024
72657-128-90 72657-128 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE May 13, 2024
72657-129-03 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-03) / 300 TABLET in 1 BOTTLE May 13, 2024
72657-129-04 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-04) / 400 TABLET in 1 BOTTLE May 13, 2024
72657-129-08 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-08) / 120 TABLET in 1 BOTTLE May 13, 2024
72657-129-14 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-14) / 140 TABLET in 1 BOTTLE May 13, 2024
72657-129-15 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-15) / 150 TABLET in 1 BOTTLE May 13, 2024
72657-129-18 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-18) / 180 TABLET in 1 BOTTLE May 13, 2024
72657-129-24 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-24) / 240 TABLET in 1 BOTTLE May 13, 2024
72657-129-30 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-30) / 30 TABLET in 1 BOTTLE May 13, 2024
72657-129-35 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-35) / 365 TABLET in 1 BOTTLE May 13, 2024
72657-129-41 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-41) / 14 TABLET in 1 BOTTLE April 3, 2025
72657-129-45 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-45) / 45 TABLET in 1 BOTTLE May 13, 2024
72657-129-60 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-60) / 60 TABLET in 1 BOTTLE May 13, 2024
72657-129-70 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-70) / 70 TABLET in 1 BOTTLE May 13, 2024
72657-129-81 72657-129 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-129-81) / 60 TABLET in 1 BOTTLE May 13, 2024
72657-129-82 72657-129 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-129-82) / 70 TABLET in 1 BOTTLE May 13, 2024
72657-129-84 72657-129 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-129-84) / 90 TABLET in 1 BOTTLE May 13, 2024
72657-129-86 72657-129 GLENMARK THERAPEUTICS INC., USA 2 BOTTLE in 1 CARTON (72657-129-86) / 120 TABLET in 1 BOTTLE May 13, 2024
72657-129-90 72657-129 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-129-90) / 90 TABLET in 1 BOTTLE May 13, 2024
79481-7640-6 79481-7640 Meijer 60 TABLET in 1 BOTTLE (79481-7640-6) September 9, 2024
70677-1279-1 70677-1279 Strategic Sourcing Services LLC 1 BOTTLE in 1 CARTON (70677-1279-1) / 14 TABLET in 1 BOTTLE April 3, 2025
70677-1279-2 70677-1279 Strategic Sourcing Services LLC 1 BOTTLE in 1 CARTON (70677-1279-2) / 30 TABLET in 1 BOTTLE March 1, 2025
70677-1279-3 70677-1279 Strategic Sourcing Services LLC 1 BOTTLE in 1 CARTON (70677-1279-3) / 60 TABLET in 1 BOTTLE March 1, 2025
70677-1279-4 70677-1279 Strategic Sourcing Services LLC 1 BOTTLE in 1 CARTON (70677-1279-4) / 90 TABLET in 1 BOTTLE March 1, 2025
70677-1279-5 70677-1279 Strategic Sourcing Services LLC 1 BOTTLE in 1 CARTON (70677-1279-5) / 300 TABLET in 1 BOTTLE March 1, 2025
72657-128 72657-128 GLENMARK THERAPEUTICS INC., USA — May 13, 2024
72657-129 72657-129 GLENMARK THERAPEUTICS INC., USA — May 13, 2024
79481-7640 79481-7640 Meijer — September 9, 2024
70677-1279 70677-1279 Strategic Sourcing Services LLC — March 1, 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 · 12 sections on this page.