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Ketotifen Fumarate Ophthalmic Solution

Ketotifen Fumarate · Solution/ Drops

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 Ophthalmic Solution

Generic name

Ketotifen Fumarate

Dosage form

Solution/ Drops

Route

Ophthalmic

Marketing category

ANDA · ANDA

Labeler

Preferred Pharmaceuticals Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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/ Drops

Route of administration

Ophthalmic

Presentations

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@FDA NDC Directory

Application number

077958

Application type

ANDA · Abbreviated New Drug Application

Approval date

July 26, 2007

Sponsor

SENTISS

Products on application

Submissions recorded

Products approved under application 077958.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
077958-001	KETOTIFEN FUMARATE	SOLUTION/DROPS		KETOTIFEN FUMARATE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 077958.
Type	No.	Action	Status	Date	Review
Supplement	11	Manufacturing (CMC)	Approved	February 19, 2014	—
Original application	1		Approved	July 26, 2007	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260415). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260415 HUMAN OTC DRUG · 20260318

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 8-12 hours, no more than twice per day. • Children under 3 years of age: Consult a doctor.

Warnings

openFDA Drug Labeling

Warnings 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.

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
72485-617-10	72485-617	Armas Pharmaceuticals Inc.	1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPER	October 9, 2023
68788-4084-5	68788-4084	Preferred Pharmaceuticals Inc.	1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER	February 27, 2026
70244-041-01	70244-041	Sentiss Pharmaceuticals LLC	1 BOTTLE, DROPPER in 1 CARTON (70244-041-01) / 5 mL in 1 BOTTLE, DROPPER	April 15, 2026
72485-617	72485-617	Armas Pharmaceuticals Inc.	—	October 9, 2023
68788-4084	68788-4084	Preferred Pharmaceuticals Inc.	—	February 27, 2026
70244-041	70244-041	Sentiss Pharmaceuticals LLC	—	April 15, 2026

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 · 10 sections on this page.