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 and older: • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • children under 3 years of age: consult a doctor
Ketotifen 0.025%
(equivalent to ketotifen fumerate 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 right away.
store at 4-25 °C (39-77 °F)
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
[Phone icon] Call: 1-800-553-5340
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 707594 | Alaway 0.025 % Ophthalmic Solution | PSN | 15 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 15 |
| 707594 | ketotifen 0.25 MG/ML Ophthalmic Solution [Alaway] | SBD | 15 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 15 |
| 707594 | Alaway 0.025 % Ophthalmic Solution | SY | 15 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 15 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 15 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 15 |
| 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 |
|---|---|---|---|---|---|---|
| 24208-601-05 | Alaway | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 15 | |
| 24208-601-05 | Alaway | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 15 | |
| 24208-601-10 | Alaway | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 15 | |
| 24208-601-10 | Alaway | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 15 | |
| 24208-601-90 | Alaway | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 15 | |
| 24208-601-90 | Alaway | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 15 | |
| 24208-601-95 | Alaway | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 15 | |
| 24208-601-95 | Alaway | 1 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 1 | 15 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24208-601-05 | ML - Milliliter | 24208-601 | 70e262e3-9f7f-4665-a66e-102f74ef9ad2 | 1 | 2014-05-02 |
| 24208-601-10 | ML - Milliliter | 24208-601 | 210a1fc5-ef5f-4d05-a59b-769c7b5c1bd1 | 1 | 2012-07-24 |
| 24208-601-90 | ML - Milliliter | 24208-601 | 8b54b237-79e9-4a15-8081-78eb258b09de | 1 | 2025-11-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| KETOTIFEN FUMARATE | ACTIVE INGREDIENT | HBD503WORO | 8 | |
| KETOTIFEN | ACTIVE MOIETY | X49220T18G | 8 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 8 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 8 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24208-601 | 24208-601-10, 24208-601-95, 24208-601-05, 24208-601-90 |
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 |
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 | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg |
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 |
|---|---|---|---|---|---|---|
| Alaway | KETOTIFEN FUMARATE | Bausch & Lomb Incorporated | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 2022-05-01 | Warnings | 24208-601-10 24208-601-95 24208-601-05 24208-601-90 24208-601 24208060110 24208060195 24208060105 24208060190 4f27a942-b5f3-4a01-8022-49deced585f8 e4c310b5-1dba-4ddc-bc90-b27ebc765871 |
Adverse event summaries are temporarily unavailable. Other product information remains available.