Eye Itch Relief

Product NDC
30142-398
11-digit product format
301420398
Labeler code
30142
Product ID
30142-398_c9bce135-e1e4-4faa-b74c-22f69a060a3e
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Kroger Company
Application
NDA021996
Marketing category
NDA
Marketing start
2022-06-01
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
30142-398-05Eye Itch Relief5 mL in 1 BOTTLESOLUTION/ DROPS55
30142-398-05Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-398EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20231215_eb81286f-72b4-42b3-a596-439d0aeae93f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNeb81286f-72b4-42b3-a596-439d0aeae93f5
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDeb81286f-72b4-42b3-a596-439d0aeae93f5
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYeb81286f-72b4-42b3-a596-439d0aeae93f5
311237ketotifen 0.025 % Ophthalmic SolutionSYeb81286f-72b4-42b3-a596-439d0aeae93f5
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYeb81286f-72b4-42b3-a596-439d0aeae93f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-398-05301420398051 BOTTLE in 1 CARTON (30142-398-05) / 5 mL in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent