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Ketotifen Fumarate

Over-the-counter NDA RLD 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/ Drops
Route
Ophthalmic
Marketing category
NDA AUTHORIZED GENERIC · NDA AG
Labeler
Rugby Laboratories
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
3
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
Ketotifen Fumarate .35 mg/mL 311237 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution/ Drops
Route of administration
Ophthalmic
Presentations
6

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
021996
Application type
NDA · New Drug Application
Approval date
December 1, 2006
Sponsor
BAUSCH AND LOMB
Products on application
2
Submissions recorded
5
Products approved under application 021996.
Product Trade name Form Strength Ingredient Status TE Flags
021996-001 ALAWAY SOLUTION/DROPS KETOTIFEN FUMARATE Over-the-counter — RLD RS
021996-002 CHILDREN'S ALAWAY SOLUTION/DROPS KETOTIFEN FUMARATE Over-the-counter — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021996.
Type No. Action Status Date Review
Supplement 17 Labeling Approved April 14, 2021 Standard
Supplement 8 Labeling Approved February 11, 2015 Standard
Supplement 5 Manufacturing (CMC) Approved February 11, 2015 Standard
Supplement 1 Manufacturing (CMC) Approved April 18, 2007 N/A
Original application 1 Type 5 - New Formulation or New Manufacturer Approved December 1, 2006 Standard

Review documents

  • 0 · Supplement · April 16, 2021
  • 0 · Supplement · February 17, 2015
  • 0 · Supplement · February 12, 2015
  • 0 · Original application · October 3, 2008
  • 0 · Supplement · April 25, 2007
  • 0 · Supplement · April 20, 2007
  • 0 · Original application · December 28, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260320). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260320 HUMAN OTC DRUG · 20230511 HUMAN OTC DRUG · 20191001

Indications and Usage

openFDA Drug Labeling

Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions Adults and children 3 years and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product Children under 3 years of age: consult a doctor

Warnings

openFDA Drug Labeling

Warnings For external use only Do not use ▪ if you are sensitive to any ingredient in this product ▪ if solution changes color or becomes cloudy ▪ to treat contact lens related irritation When using this product ▪ remove contact lenses before use ▪ wait at least 10 minutes before re-inserting contact lenses after use ▪ do not touch tip of container to any surface to avoid contamination ▪ replace cap after each use Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours

Active Ingredient

openFDA Drug Labeling

Active ingredient Ketotifen (0.025%) (equivalent to Ketotifen Fumarate 0.035%)

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6472 NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON

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
50090-6472-0 50090-6472 A-S Medication Solutions 1 BOTTLE, DROPPER in 1 CARTON (50090-6472-0) / 5 mL in 1 BOTTLE, DROPPER May 10, 2023
71205-115-05 71205-115 Proficient Rx LP 1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPER September 4, 2018
0536-1252-40 0536-1252 Rugby Laboratories 1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER September 18, 2020
50090-6472 50090-6472 A-S Medication Solutions — September 18, 2020
71205-115 71205-115 Proficient Rx LP — October 1, 2007
0536-1252 0536-1252 Rugby Laboratories — September 18, 2020

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 · 12 sections on this page.