Indications and uses
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Adults and children 3 years or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: consult a doctor Store at 4-25°C (39-77°F)
Ketotifen 0.025%
(equivalent to ketotifen fumarate 0.035%)
Antihistamine
For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
For external use only
Do not use
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Adults and children 3 years or older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.
Children under 3 years of age: consult a doctor
Store at 4-25°C (39-77°F)
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 3 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 3 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 3 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 3 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| KETOTIFEN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-231-10 | Equate Eye Itch Relief | 1 in 1 CARTON | SOLUTION | 1 | 3 | |
| 49035-231-10 | Equate Eye Itch Relief | 10 mL in 1 BOTTLE | SOLUTION | 10 | 3 | |
| 49035-231-11 | Equate Eye Itch Relief | 10 mL in 1 BOTTLE | SOLUTION | 10 | 3 | |
| 49035-231-11 | Equate Eye Itch Relief | 2 in 1 CARTON | SOLUTION | 2 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-231-10 | ML - Milliliter | 49035-231 | 53508346-77a0-4fcb-b4b6-260c5be00e87 | 1 | 2023-03-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49035-231 | 49035-231-10, 49035-231-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| KETOTIFEN FUMARATE | HBD503WORO | ACTIM |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|---|
| N021996-001 | ALAWAY | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | |
| N021996-002 | CHILDREN'S ALAWAY | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 |
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 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021996-002 | CHILDREN'S ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021996-002 | ALAWAY | EQ 0.035% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021996-001 | ALAWAY | EQ 0.025% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2006-12-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021996-002 | ALAWAY | EQ 0.035% BASE | SOLUTION/DROPS / OPHTHALMIC | RLD | 2015-02-11 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Equate Eye Itch Relief | KETOTIFEN FUMARATE | Wal-Mart Stores, Inc. | accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9 | 2021-03-23 | Warnings | 49035-231-11 49035-231-10 49035-231 49035023110 49035023111 23a94887-f625-4a01-bcda-131ca5286372 accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.