Alaway

Manufacturer
Bausch & Lomb Incorporated
Effective date
2022-05-01
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-05-31 23:49:36

Label at a glance#

ProductAlaway
Active ingredientKETOTIFEN FUMARATE
Label structure9 sections

Indications and uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

WARNINGS SECTION

For external use only

Do not use

  • if you are sensitive to any ingredient in this product
  • if solution changes color or becomes cloudy
  • to treat contact lens related irritation

When using this product

OTC - WHEN USING SECTION

  • remove contact lenses before use
  • wait at least 10 minutes before re-inserting contact lenses after use
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if you experience any of the following:

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that worsens or lasts for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

store at 4-25 °C (39-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions or comments?

OTC - QUESTIONS SECTION

[Phone icon] Call: 1-800-553-5340

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

TWIN PACK

NDC 24208-601-90

BAUSCH + LOMB

Alaway®

ketotifen fumarate
ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Eye Itch
Relief

UP TO
12
HOURS

Works in Minutes

Original Prescription Strength

For Ages 3 Years And Older

2x 10 mL BOTTLES

STERILE 0.34 FL OZ EACH

3842002

AB60192A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
707594Alaway 0.025 % Ophthalmic SolutionPSN15
311237ketotifen 0.025 % Ophthalmic SolutionPSN15
707594ketotifen 0.25 MG/ML Ophthalmic Solution [Alaway]SBD15
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD15
707594Alaway 0.025 % Ophthalmic SolutionSY15
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY15
311237ketotifen 0.025 % Ophthalmic SolutionSY15
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOTIFEN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-601-05Alaway5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS515
24208-601-05Alaway1 in 1 CARTONSOLUTION/ DROPS115
24208-601-10Alaway1 in 1 CARTONSOLUTION/ DROPS115
24208-601-10Alaway10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1015
24208-601-90Alaway10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1015
24208-601-90Alaway2 in 1 CARTONSOLUTION/ DROPS215
24208-601-95Alaway1 in 1 CARTONSOLUTION/ DROPS115
24208-601-95Alaway1 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-601ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]15Current NDC, Legacy NDC, 8 package rows20220518_e4c310b5-1dba-4ddc-bc90-b27ebc765871.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-601-05ML - Milliliter24208-60170e262e3-9f7f-4665-a66e-102f74ef9ad212014-05-02
24208-601-10ML - Milliliter24208-601210a1fc5-ef5f-4d05-a59b-769c7b5c1bd112012-07-24
24208-601-90ML - Milliliter24208-6018b54b237-79e9-4a15-8081-78eb258b09de12025-11-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
KETOTIFEN FUMARATEACTIVE INGREDIENTHBD503WORO8
KETOTIFENACTIVE MOIETYX49220T18G8
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W78
GLYCERININACTIVE INGREDIENTPDC6A3C0OX8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I8
WATERINACTIVE INGREDIENT059QF0KO0R8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24208-60124208-601-10, 24208-601-95, 24208-601-05, 24208-601-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021996-001ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01
N021996-002CHILDREN'S ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0184e616aacf4f…
2026-09-14 22:38:342026-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1184e616aacf4f…
2026-08-18 06:07:402026-07N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021996-002CHILDREN'S ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021996-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2006-12-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021996-002ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMICRLD2015-02-1174a2ff9319b5…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlawayKETOTIFEN FUMARATEBausch & Lomb Incorporatede4c310b5-1dba-4ddc-bc90-b27ebc7658712022-05-01WarningsExact identifier
ndc (package): 24208-601-10
ndc (package): 24208-601-95
ndc (package): 24208-601-05
ndc (package): 24208-601-90
ndc (product): 24208-601
ndc11 (package): 24208060110
ndc11 (package): 24208060195
ndc11 (package): 24208060105
ndc11 (package): 24208060190
spl id: 4f27a942-b5f3-4a01-8022-49deced585f8
spl set id: e4c310b5-1dba-4ddc-bc90-b27ebc765871

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.