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Cetirizine Hydrochloride (Allergy)
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 (Allergy)
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
17
Packages
72
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet
Route of administration
Oral
Presentations
89
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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 DirectoryApplication 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
| 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| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | August 5, 2015 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced 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 HUMAN OTC DRUG · 20260129 HUMAN OTC DRUG · 20240301
Indications and Usage
openFDA Drug LabelingUses 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 LabelingPurpose Antihistamine
Dosage and Administration
openFDA Drug LabelingDirections For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; 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 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
openFDA Drug LabelingWarnings 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 LabelingAsk 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 LabelingStop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride USP 10 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-6168 NDC: 50090-6168-1 30 TABLET in a BOTTLE NDC: 50090-6168-3 90 TABLET in a BOTTLE
Adverse event reports
Source: openFDA FAERS166,303
FAERS reports mentioning this drug
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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-6168-1 | 50090-6168 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6168-1) | October 26, 2022 |
| 50090-6168-3 | 50090-6168 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6168-3) | August 2, 2023 |
| 50090-6170-0 | 50090-6170 | A-S Medication Solutions | 48 BOTTLE in 1 CASE (50090-6170-0) / 30 TABLET in 1 BOTTLE | October 13, 2022 |
| 50090-6950-0 | 50090-6950 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6950-0) | December 19, 2023 |
| 50090-6950-1 | 50090-6950 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6950-1) | January 28, 2026 |
| 58602-444-09 | 58602-444 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-444-09) / 30 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-444-17 | 58602-444 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-444-17) / 45 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-444-21 | 58602-444 | Aurohealth LLC | 10 BLISTER PACK in 1 CARTON (58602-444-21) / 10 TABLET in 1 BLISTER PACK | August 5, 2015 |
| 58602-444-41 | 58602-444 | Aurohealth LLC | 1000 TABLET in 1 BOTTLE (58602-444-41) | August 5, 2015 |
| 58602-444-47 | 58602-444 | Aurohealth LLC | 75 TABLET in 1 PACKAGE, COMBINATION (58602-444-47) | August 5, 2015 |
| 58602-445-01 | 58602-445 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-445-01) / 14 TABLET in 1 BLISTER PACK | August 5, 2015 |
| 58602-445-09 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-09) / 30 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-445-15 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-15) / 60 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-445-17 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-17) / 45 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-445-19 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-19) / 90 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-445-21 | 58602-445 | Aurohealth LLC | 10 BLISTER PACK in 1 CARTON (58602-445-21) / 10 TABLET in 1 BLISTER PACK | August 5, 2015 |
| 58602-445-23 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-23) / 120 TABLET in 1 BOTTLE | August 6, 2026 |
| 58602-445-38 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-38) / 300 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-445-39 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-39) / 365 TABLET in 1 BOTTLE | August 6, 2026 |
| 58602-445-40 | 58602-445 | Aurohealth LLC | 500 TABLET in 1 BOTTLE (58602-445-40) | August 5, 2015 |
| 58602-445-41 | 58602-445 | Aurohealth LLC | 1000 TABLET in 1 BOTTLE (58602-445-41) | August 5, 2015 |
| 58602-445-47 | 58602-445 | Aurohealth LLC | 75 TABLET in 1 PACKAGE, COMBINATION (58602-445-47) | August 5, 2015 |
| 58602-445-54 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-54) / 70 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-445-60 | 58602-445 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-445-60) / 5 TABLET in 1 BLISTER PACK | August 5, 2015 |
| 58602-445-65 | 58602-445 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-445-65) / 7 TABLET in 1 BLISTER PACK | November 21, 2019 |
| 58602-445-94 | 58602-445 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-445-94) / 100 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-812-04 | 58602-812 | Aurohealth LLC | 10 BLISTER PACK in 1 CARTON (58602-812-04) / 10 TABLET in 1 BLISTER PACK (58602-812-83) | August 5, 2015 |
| 58602-812-09 | 58602-812 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-812-09) / 30 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-812-17 | 58602-812 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-812-17) / 45 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-812-23 | 58602-812 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-812-23) / 120 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-812-39 | 58602-812 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-812-39) / 365 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-812-41 | 58602-812 | Aurohealth LLC | 1000 TABLET in 1 BOTTLE (58602-812-41) | August 5, 2015 |
| 58602-812-99 | 58602-812 | Aurohealth LLC | 75 TABLET in 1 PACKAGE, COMBINATION (58602-812-99) | August 5, 2015 |
| 58602-823-39 | 58602-823 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-823-39) / 365 TABLET in 1 BOTTLE | August 5, 2015 |
| 58602-861-40 | 58602-861 | Aurohealth LLC | 500 TABLET in 1 BOTTLE (58602-861-40) | May 25, 2026 |
| 21130-098-23 | 21130-098 | Better Living Brands, LLC | 1 BOTTLE in 1 CARTON (21130-098-23) / 120 TABLET in 1 BOTTLE | February 10, 2023 |
| 68001-436-04 | 68001-436 | BluePoint Laboratories | 1 BOTTLE in 1 CARTON (68001-436-04) / 30 TABLET in 1 BOTTLE | June 19, 2020 |
| 68001-436-96 | 68001-436 | BluePoint Laboratories | 10 BLISTER PACK in 1 CARTON (68001-436-96) / 10 TABLET in 1 BLISTER PACK (68001-436-16) | June 19, 2020 |
| 68001-436-97 | 68001-436 | BluePoint Laboratories | 1 BOTTLE in 1 CARTON (68001-436-97) / 300 TABLET in 1 BOTTLE | June 19, 2020 |
| 69842-237-01 | 69842-237 | CVS Pharmacy, Inc. | 1 BLISTER PACK in 1 CARTON (69842-237-01) / 14 TABLET in 1 BLISTER PACK | July 26, 2019 |
| 69842-237-09 | 69842-237 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (69842-237-09) / 30 TABLET in 1 BOTTLE | July 26, 2019 |
| 69842-237-17 | 69842-237 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (69842-237-17) / 45 TABLET in 1 BOTTLE | July 26, 2019 |
| 69842-237-19 | 69842-237 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (69842-237-19) / 90 TABLET in 1 BOTTLE | July 26, 2019 |
| 69842-237-23 | 69842-237 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (69842-237-23) / 120 TABLET in 1 BOTTLE | July 26, 2019 |
| 69842-237-39 | 69842-237 | CVS Pharmacy, Inc. | 365 TABLET in 1 BOTTLE (69842-237-39) | July 26, 2019 |
| 69842-237-45 | 69842-237 | CVS Pharmacy, Inc. | 2 BOTTLE in 1 CARTON (69842-237-45) / 120 TABLET in 1 BOTTLE | July 26, 2019 |
| 57483-190-14 | 57483-190 | INNOVUS PHARMACEUTICALS, INC. | 365 TABLET in 1 BOTTLE (57483-190-14) | April 28, 2025 |
| 30142-172-09 | 30142-172 | KROGER COMPANY | 1 BOTTLE in 1 CARTON (30142-172-09) / 30 TABLET in 1 BOTTLE | March 15, 2021 |
| 30142-172-54 | 30142-172 | KROGER COMPANY | 1 BOTTLE in 1 CARTON (30142-172-54) / 70 TABLET in 1 BOTTLE | March 15, 2021 |
| 16714-799-01 | 16714-799 | NorthStar Rx LLC | 30 TABLET in 1 BOTTLE (16714-799-01) | August 5, 2015 |
| 16714-799-02 | 16714-799 | NorthStar Rx LLC | 100 TABLET in 1 BOTTLE (16714-799-02) | August 5, 2015 |
| 16714-799-03 | 16714-799 | NorthStar Rx LLC | 300 TABLET in 1 BOTTLE (16714-799-03) | August 5, 2015 |
| 16714-799-04 | 16714-799 | NorthStar Rx LLC | 500 TABLET in 1 BOTTLE (16714-799-04) | August 5, 2015 |
| 68788-8204-0 | 68788-8204 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8204-0) | April 1, 2022 |
| 68788-8204-1 | 68788-8204 | Preferred Pharmaceuticals Inc. | 14 TABLET in 1 BOTTLE (68788-8204-1) | April 1, 2022 |
| 68788-8204-3 | 68788-8204 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8204-3) | April 1, 2022 |
| 68788-8204-5 | 68788-8204 | Preferred Pharmaceuticals Inc. | 15 TABLET in 1 BOTTLE (68788-8204-5) | April 1, 2022 |
| 68788-8204-6 | 68788-8204 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8204-6) | April 1, 2022 |
| 68788-8204-9 | 68788-8204 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8204-9) | April 1, 2022 |
| 71205-700-00 | 71205-700 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-700-00) | March 8, 2024 |
| 71205-700-06 | 71205-700 | Proficient Rx LP | 6 TABLET in 1 BOTTLE (71205-700-06) | January 29, 2024 |
| 71205-700-10 | 71205-700 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (71205-700-10) | October 20, 2022 |
| 71205-700-12 | 71205-700 | Proficient Rx LP | 12 TABLET in 1 BOTTLE (71205-700-12) | January 29, 2024 |
| 71205-700-14 | 71205-700 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (71205-700-14) | January 29, 2024 |
| 71205-700-15 | 71205-700 | Proficient Rx LP | 15 TABLET in 1 BOTTLE (71205-700-15) | January 29, 2024 |
| 71205-700-20 | 71205-700 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (71205-700-20) | January 29, 2024 |
| 71205-700-21 | 71205-700 | Proficient Rx LP | 21 TABLET in 1 BOTTLE (71205-700-21) | January 29, 2024 |
| 71205-700-30 | 71205-700 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-700-30) | September 16, 2022 |
| 71205-700-60 | 71205-700 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-700-60) | September 16, 2022 |
| 71205-700-72 | 71205-700 | Proficient Rx LP | 120 TABLET in 1 BOTTLE (71205-700-72) | March 8, 2024 |
| 71205-700-90 | 71205-700 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-700-90) | September 16, 2022 |
| 0363-9602-09 | 0363-9602 | WALGREEN CO. | 1 BOTTLE in 1 CARTON (0363-9602-09) / 30 TABLET in 1 BOTTLE | July 5, 2021 |
| 50090-6168 | 50090-6168 | A-S Medication Solutions | — | August 5, 2015 |
| 50090-6170 | 50090-6170 | A-S Medication Solutions | — | August 5, 2015 |
| 50090-6950 | 50090-6950 | A-S Medication Solutions | — | August 5, 2015 |
| 58602-444 | 58602-444 | Aurohealth LLC | — | August 5, 2015 |
| 58602-445 | 58602-445 | Aurohealth LLC | — | August 5, 2015 |
| 58602-812 | 58602-812 | Aurohealth LLC | — | August 5, 2015 |
| 58602-823 | 58602-823 | Aurohealth LLC | — | August 5, 2015 |
| 58602-861 | 58602-861 | Aurohealth LLC | — | February 10, 2023 |
| 21130-098 | 21130-098 | Better Living Brands, LLC | — | February 10, 2023 |
| 68001-436 | 68001-436 | BluePoint Laboratories | — | June 19, 2020 |
| 69842-237 | 69842-237 | CVS Pharmacy, Inc. | — | July 26, 2019 |
| 57483-190 | 57483-190 | INNOVUS PHARMACEUTICALS, INC. | — | April 28, 2025 |
| 30142-172 | 30142-172 | KROGER COMPANY | — | March 15, 2021 |
| 16714-799 | 16714-799 | NorthStar Rx LLC | — | August 5, 2015 |
| 68788-8204 | 68788-8204 | Preferred Pharmaceuticals Inc. | — | April 1, 2022 |
| 71205-700 | 71205-700 | Proficient Rx LP | — | August 5, 2015 |
| 0363-9602 | 0363-9602 | WALGREEN CO. | — | July 5, 2021 |
Sources for 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.