Eye Itch Relief

Product NDC
21130-601
11-digit product format
211300601
Labeler code
21130
Product ID
21130-601_38519d56-77cc-43cc-9b74-6ef2fc796a0d
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Safeway
Application
NDA021996
Marketing category
NDA
Marketing start
2014-08-20
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
21130-601-05Eye Itch Relief5 mL in 1 BOTTLESOLUTION55
21130-601-05Eye Itch Relief1 in 1 CARTONSOLUTION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOTIFEN FUMARATEACTIVE INGREDIENTHBD503WOROEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1
KETOTIFENACTIVE MOIETYX49220T18GEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1
WATERINACTIVE INGREDIENT059QF0KO0REYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-601EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [SAFEWAY]5Current NDC, Legacy NDC, 2 package rows20240514_5fccbb63-7859-484c-b7b3-9de711364c09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN5fccbb63-7859-484c-b7b3-9de711364c095
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD5fccbb63-7859-484c-b7b3-9de711364c095
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY5fccbb63-7859-484c-b7b3-9de711364c095
311237ketotifen 0.025 % Ophthalmic SolutionSY5fccbb63-7859-484c-b7b3-9de711364c095
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY5fccbb63-7859-484c-b7b3-9de711364c095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-601-05211300601051 BOTTLE in 1 CARTON (21130-601-05) / 5 mL in 1 BOTTLE1 bottle2014-08-200000-00-00NoNoCurrent