Quick answers
- What is Cetirizine used for?
- The FDA-approved label (Zerviate, Harrow Eye, LLC, August 3, 2026) says: “ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cetirizine have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cetirizine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cetirizine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cetirizine?
- 18 companies list prescription products of Cetirizine in the FDA NDC Directory, including Preferred Pharmaceuticals Inc., Bajaj Medical, LLC and Advagen Pharma Ltd.
What Cetirizine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.
— FDA label: Zerviate, Harrow Eye, LLC, effective August 3, 2026. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cetirizine 2.4 mg/mL for solution | Brand: Zerviate | $7.35 per unit |
| cetirizine hydrochloride 1 mg/mL solution | Generic | $0.0219–$0.0928 per mL 11 packages, lowest to highest |
| cetirizine hydrochloride 5 mg/5 mL solution | Generic | $0.0219–$0.3318 per mL 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Preferred Pharmaceuticals Inc.3 products
- Bajaj Medical, LLC2 products
- Advagen Pharma Ltd1 product
- Proficient Rx LP1 product
- Bionpharma Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.1 product
- Padagis Israel Pharmaceuticals Ltd1 product
- A-S Medication Solutions1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Aventura Pharmaceuticals, LLC1 product
- Apozeal Pharmaceuticals Inc1 product
- Chartwell RX, LLC1 product
- Esteve Pharmaceuticals, S.A.1 product
- TerSera Therapeutics LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Harrow Eye, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208694 ZERVIATE | Harrow Eye | May 30, 2017 | 1, latest February 5, 2020 2020: Labeling |
| NDA211415 QUZYTTIR | Esteve | October 4, 2019 | 2, latest July 28, 2025 2025: Labeling · 2019: Labeling |
Generic approvals (9)
- ANDA078398Padagis Us · June 17, 2008
- ANDA078412Pharm Assoc · June 18, 2008
- ANDA076601Taro · June 20, 2008
- ANDA078488Bionpharma · October 6, 2008
- ANDA078870Pharmazone · April 27, 2009
- ANDA090766Amneal Pharms · October 7, 2009
- ANDA090191Bajaj · November 12, 2009
- ANDA078876Chartwell Molecular · May 11, 2012
- ANDA220335Rubicon Research · February 25, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zerviate, Harrow Eye, LLC, effective August 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →