OTC - ACTIVE INGREDIENT SECTION
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
KETOTIFEN FUMARATE
- Manufacturer
- DIRECT RX
- Effective date
- 2021-05-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:44:31
Label at a glance#
ProductKETOTIFEN FUMARATE
Active ingredientKETOTIFEN FUMARATE
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Antihistamine
OTC - WHEN USING SECTION
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
WARNINGS SECTION
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.
INSTRUCTIONS FOR USE SECTION
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.
OTC - QUESTIONS SECTION
Only for use in the eye.
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
INACTIVE INGREDIENT SECTION
benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium hydroxide, and water for injection
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-114-05 | ML - Milliliter | 72189-114 | 2d84caf6-58ae-44f5-84dc-5f6e04c804ba | 1 | 2020-08-06 |
| 72189-212-05 | ML - Milliliter | 72189-212 | 9dc07e04-6f95-4e67-bdc7-2ef13251b1c4 | 1 | 2021-06-02 |
| 60505-6215-1 | ML - Milliliter | 60505-6215 | cecf5c51-703c-4d7a-9593-8787e0b03386 | 1 | 2020-02-13 |
| 17478-717-10 | ML - Milliliter | 17478-717 | ce0e369a-3af1-4d5f-acd2-f493a3cfb1a6 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- KETOTIFEN FUMARATE
- HYDROCHLORIC ACID
- KETOTIFEN
- SODIUM HYDROXIDE
- BENZALKONIUM CHLORIDE
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-114 | 72189-114-05 |
| 72189-212 | 72189-212-05 |
| 60505-6215 | |
| 17478-717 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| KETOTIFEN FUMARATE | HBD503WORO | ACTIM |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| KETOTIFEN FUMARATE | HBD503WORO | ACTIM |
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 |
|---|---|---|---|---|---|---|---|
| A077354-001 | KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 |
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 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077354-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2006-05-09 | f41ea6bd6efb… |
Orange Book products#
| 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 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 | 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077958-001 | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | 2007-07-26 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 01546816-4455-90b5-e063-6394a90a1391 | a8ee2e96-d09a-d0fe-e053-2a95a90a30b1 | 2023-07-25 | Warnings | a8ee2e96-d09a-d0fe-e053-2a95a90a30b1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.