Indications and uses
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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.
Drug Facts
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
Antihistamine
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Stop use and ask a doctor if you experience any of the following:
If swallowed, get medical help or contact a Poison Control Center right away.
Benzalkonium Chloride 0.01%, Glycerin, Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
1-800-932-5676
Principal Display Panel Text for Carton Label:
NDC 61715-091-71
Preferred plus Pharmacy Logo® *Compare to the active
ingredient in Zaditor®
EYE ITCH
RELIEF
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
UP TO
12
HOURS
ITCH RELIEF
SATISFACTION GUARANTEED Logo
5 mL (0.17 FL OZ) STERILE

| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ketotifen Fumarate | ACTIVE INGREDIENT | HBD503WORO | 1 | |
| Ketotifen | ACTIVE MOIETY | X49220T18G | 1 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61715-091 | 61715-091-71 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Ketotifen Fumarate | HBD503WORO | ACTIM |
| Benzalkonium Chloride | F5UM2KM3W7 | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Water | 059QF0KO0R | IACT |
| Hydrochloric Acid | QTT17582CB | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, EMULSION / INTRAMUSCULAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAVITREAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 1.5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / RETROBULBAR | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LIQUID / NASAL | 0.2 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IONTOPHORESIS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SOLUTION / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAMUSCULAR | 176 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SPRAY, METERED / NASAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SOFT TISSUE | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | CAPSULE, LIQUID FILLED / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPONGE / TOPICAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAUDAL | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / OPHTHALMIC | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTERSTITIAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAMUSCULAR | 1037 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SYRUP / ORAL | 2.03 mg/1ml | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / IONTOPHORESIS | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY, METERED / NASAL | 1 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRASYNOVIAL | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRATUMOR | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRATUMOR | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SYRUP / ORAL | 71 mg/5ml | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / SUBCUTANEOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INFILTRATION | ADJ PH | ||
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / OPHTHALMIC | 2 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / DENTAL | ADJ PH | ||
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRACAUDAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | LIQUID / NASAL | ADJ PH |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077958-001 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 98ee5b75-5008-42c8-bc5f-659df6ad9af9 | c22019aa-1d6a-4494-a425-5ff0b9261d83 | 2014-03-18 | Warnings | 98ee5b75-5008-42c8-bc5f-659df6ad9af9 c22019aa-1d6a-4494-a425-5ff0b9261d83 |
Adverse event summaries are temporarily unavailable. Other product information remains available.