Eye Itch Relief

Product NDC
11673-064
11-digit product format
116730064
Labeler code
11673
Product ID
11673-064_316940f0-2e63-f04f-e063-6394a90ae1a3
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Target Corporation
Application
NDA021996
Marketing category
NDA
Marketing start
2014-01-02
Substance
KETOTIFEN FUMARATE
Active strength
.25 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eye Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOTIFEN FUMARATE.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHBD503WORO
Rxcui311237

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
11673-064-05Eye Itch Relief5 mL in 1 BOTTLESOLUTION55
11673-064-05Eye Itch Relief1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-064EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [TARGET CORPORATION]5Current NDC, Legacy NDC, 2 package rows20250331_b25106f8-436e-4c06-8780-b12368ede9fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNb25106f8-436e-4c06-8780-b12368ede9fe5
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDb25106f8-436e-4c06-8780-b12368ede9fe5
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYb25106f8-436e-4c06-8780-b12368ede9fe5
311237ketotifen 0.025 % Ophthalmic SolutionSYb25106f8-436e-4c06-8780-b12368ede9fe5
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYb25106f8-436e-4c06-8780-b12368ede9fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-064-05116730064051 BOTTLE in 1 CARTON (11673-064-05) / 5 mL in 1 BOTTLE1 bottle2014-01-020000-00-00NoNoCurrent