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#
Contacts and useful links#
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 2 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 2 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 2 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 2 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| KETOTIFEN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76385-106-17 | KETOTIFEN FUMARATE | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | 2 | |
| 76385-106-17 | KETOTIFEN FUMARATE | 1 in 1 CARTON | SOLUTION | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76385-106-17 | ML - Milliliter | 76385-106 | 52aeb84b-fce7-4594-8717-c726c4d5c988 | 1 | 2021-11-09 |
Products#
Every source-derived product name is available through these pages.
- KETOTIFEN FUMARATE
- KETOTIFEN
- GLYCERIN
- SODIUM HYDROXIDE
- HYDROCHLORIC ACID
- BENZALKONIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76385-106 | 76385-106-17 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| KETOTIFEN FUMARATE | HBD503WORO | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204059-001 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204059-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2020-06-01 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | Unichem Pharmaceuticals (USA), Inc. | 0fe119ad-cb44-4e90-a096-0ed0ba63dc31 | 2025-11-24 | 76385-106-17 76385-106 76385010617 948d4259-9d62-4bc7-9149-6961034364bf 0fe119ad-cb44-4e90-a096-0ed0ba63dc31 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

