Over-the-counter medicine
Ketotifen Brand names: Eye, Alaway, Equate; first approved as Zaditor
Ketotifen (Eye) is an over-the-counter medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $1.29 per mL (Ketotifen 0.025% (0.035%) drop) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the ketotifen FDA label on DailyMed (effective May 1, 2022, Bausch & Lomb Incorporated); the NDA 21066 record on Drugs@FDA; every ketotifen label on DailyMed.
Highlights of the record
FDA label of May 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagefor the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Forms and strengths
- 0.25 mg/ml
- 0.35 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- July 2, 1999 Zaditor, Alcon Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first May 9, 2006; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 7 under generic applications, 12 under brand applications, repackagers included
- Last listed patent
- June 27, 2030 Acuvue Theravision With Ketotifen drug-eluting contact lens; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.29 per mL Ketotifen 0.025% (0.035%) drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest June 29, 2022
- FAERS reports
- 6,491 through July 30, 2026
What is ketotifen used for?
From the label: indications and usagefor the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
FDA pharmacologic class: Histamine-1 Receptor Inhibitor.
Source: FDA drug label (Alaway), Bausch & Lomb Incorporated, effective May 1, 2022 (SPL set e4c310b5-1dba-4ddc-bc90-b27ebc765871), via openFDA; the full label on DailyMed
Is there a generic for ketotifen (Eye)?
The FDA approved the first generic ketotifen on May 9, 2006. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ketotifen from 7 labelers under a generic (ANDA) application and from 12 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Alaway solution/drops; a patent listed only for Acuvue Theravision With Ketotifen drug-eluting contact lens runs to June 27, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1999 earliest approval on file
- 2006 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ketotifen (Eye)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.29 per mL (Ketotifen 0.025% (0.035%) drop), down 9% from $1.42 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ketotifen 0.025% (0.035%) drop (generic)
- Zaditor 0.025% (0.035%) drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Eye itch relief 0.025% drops | Generic | $1.29 per mL | n/a | -9% |
| Ketotifen 0.025% (0.035%) drop | Generic | $1.29 per mL | n/a | -9% |
| Zaditor 0.025% (0.035%) drops | Brand | $2.05 per mL | n/a | +0.9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ketotifen been recalled?
The FDA's Enforcement Report lists 1 recall naming ketotifen since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 29, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations: products were stored outside the drug label specifications. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for ketotifen?
The FDA Adverse Event Reporting System holds 6,491 reports that list ketotifen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 492 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (2,481, against a median of 303 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other histamine-1 receptor inhibitors
- the pharmacologic class, with prices and generics
- Ketotifen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other