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KETOTIFEN FUMARATE

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
KETOTIFEN FUMARATE
Generic name
Ketotifen Fumarate
Dosage form
Solution
Route
Ophthalmic
Marketing category
ANDA · ANDA
Labeler
Unichem Pharmaceuticals (USA), Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ketotifen Fumarate .25 mg/mL 311237 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Ophthalmic
Presentations
4

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 Inhibitor [EPC] EPC All 19 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
204059
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 1, 2020
Sponsor
UNICHEM
Products on application
1
Submissions recorded
1
Products approved under application 204059.
Product Trade name Form Strength Ingredient Status TE Flags
204059-001 KETOTIFEN FUMARATE SOLUTION/DROPS KETOTIFEN FUMARATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 204059.
Type No. Action Status Date Review
Original application 1 Approved June 1, 2020 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260515). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260515

Indications and Usage

openFDA Drug Labeling

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. • Children under 3 years of age: Consult a doctor.

Warnings

openFDA Drug Labeling

Warnings For external use only Do not use • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation When using this product • do not touch tip of container to any surface to avoid contamination • remove contact lenses before use • wait at least 10 minutes before reinserting contact lenses after use • replace cap after each use Stop use and ask a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eye • itching worsens or lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

Do not use • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eye • itching worsens or lasts for more than 72 hours

Active Ingredient

openFDA Drug Labeling

Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Adverse event reports

Source: openFDA FAERS
6,493
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: KETOTIFEN FUMARATE. 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
68788-8715-5 68788-8715 Preferred Pharmaceuticals Inc. 1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5) / 5 mL in 1 BOTTLE, PLASTIC July 12, 2024
76385-106-17 76385-106 Unichem Pharmaceuticals (USA), Inc. 1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC October 15, 2021
68788-8715 68788-8715 Preferred Pharmaceuticals Inc. — July 12, 2024
76385-106 76385-106 Unichem Pharmaceuticals (USA), Inc. — October 15, 2021

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.