KETOTIFEN FUMARATE

Manufacturer
Unichem Pharmaceuticals (USA), Inc. | Unichem Laboratories Limited, India | Indoco Remedies Limited
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:41

Label at a glance#

ProductKETOTIFEN FUMARATE
Active ingredientKETOTIFEN FUMARATE
Label structure3 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

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.

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.

Other information

  • Only for use in the eye.
  • Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid.

Questions?

Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number.

Made in India

Distributed by:

UNICHEM PHARMACEUTICALS (USA), INC.

East Brunswick, NJ 08816 USA

Rev. 11/2025

KFO1236

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76385-106-17

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ)

Sterile

ketotifenfumaratelabel
ketotifenfumaratelabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76385-106-17

Now OTC

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

 5 mL (0.17 FL OZ)

 Sterile

ketotifenfumaratecarton
ketotifenfumaratecarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN2
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD2
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY2
311237ketotifen 0.025 % Ophthalmic SolutionSY2
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOTIFEN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-106-17KETOTIFEN FUMARATE5 mL in 1 BOTTLE, PLASTICSOLUTION52
76385-106-17KETOTIFEN FUMARATE1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-106-17ML - Milliliter76385-10652aeb84b-fce7-4594-8717-c726c4d5c98812021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76385-10676385-106-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204059-001KETOTIFEN FUMARATEKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0184e616aacf4f…
2026-08-18 06:07:402026-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETOTIFEN FUMARATEKETOTIFEN FUMARATEUnichem Pharmaceuticals (USA), Inc.0fe119ad-cb44-4e90-a096-0ed0ba63dc312025-11-24Exact identifier
ndc (package): 76385-106-17
ndc (product): 76385-106
ndc11 (package): 76385010617
spl id: 948d4259-9d62-4bc7-9149-6961034364bf
spl set id: 0fe119ad-cb44-4e90-a096-0ed0ba63dc31

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.