FDA.reportPublic FDA data

Eye Itch Relief

Product NDC
50804-601
11-digit product format
508040601
Labeler code
50804
Product ID
50804-601_48728697-b0d0-e765-e063-6294a90a6041
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
PERRIGO DIRECT INC.
Application
NDA021996
Marketing category
NDA
Marketing start
2024-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eye Itch Relief
Listing expiration
2027-12-31

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
50804-601-05Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS13
50804-601-05Eye Itch Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-601-05ML - Milliliter50804-60163b8c587-3c48-4981-994b-15d11ebd62e812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-601EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [PERRIGO DIRECT INC.]2Current NDC, 2 package rows20240410_d3049296-0d15-4523-883c-25f8817bc735.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNd3049296-0d15-4523-883c-25f8817bc7353
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDd3049296-0d15-4523-883c-25f8817bc7353
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYd3049296-0d15-4523-883c-25f8817bc7353
311237ketotifen 0.025 % Ophthalmic SolutionSYd3049296-0d15-4523-883c-25f8817bc7353
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYd3049296-0d15-4523-883c-25f8817bc7353
311237ketotifen 0.025 % Ophthalmic SolutionPSNb0eb7b54-4f4e-4ca2-8e4e-30d18d6624011
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDb0eb7b54-4f4e-4ca2-8e4e-30d18d6624011
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYb0eb7b54-4f4e-4ca2-8e4e-30d18d6624011
311237ketotifen 0.025 % Ophthalmic SolutionSYb0eb7b54-4f4e-4ca2-8e4e-30d18d6624011
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYb0eb7b54-4f4e-4ca2-8e4e-30d18d6624011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50804-601-05508040601051 BOTTLE, DROPPER in 1 CARTON (50804-601-05) / 5 mL in 1 BOTTLE, DROPPER2024-04-01NoNoHistorical