FDA.reportPublic FDA data

Eye Itch Relief

Product NDC
70000-0522
11-digit product format
700000522
Labeler code
70000
Product ID
70000-0522_5f7ef9e0-7c0a-4e3e-b943-e1b47e3e2623
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Cardinal Health
Application
NDA021996
Marketing category
NDA
Marketing start
2020-08-07
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
70000-0522-1Eye Itch Relief5 mL in 1 BOTTLESOLUTION53
70000-0522-1Eye Itch Relief1 in 1 CARTONSOLUTION13
70000-0522-2Eye Itch Relief10 mL in 1 BOTTLESOLUTION103
70000-0522-2Eye Itch Relief1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0522-1ML - Milliliter70000-0522b75ca683-9915-48dd-b245-269d3301da6412021-06-02
70000-0522-2ML - Milliliter70000-0522cbe4f61b-7214-46c2-82fd-54d0492148b512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0522EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [CARDINAL HEALTH]3Current NDC, Legacy NDC, 4 package rows20231215_e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNe5fd1246-c4a7-4be3-a3d3-83d82ec6cab83
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDe5fd1246-c4a7-4be3-a3d3-83d82ec6cab83
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYe5fd1246-c4a7-4be3-a3d3-83d82ec6cab83
311237ketotifen 0.025 % Ophthalmic SolutionSYe5fd1246-c4a7-4be3-a3d3-83d82ec6cab83
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYe5fd1246-c4a7-4be3-a3d3-83d82ec6cab83
311237ketotifen 0.025 % Ophthalmic SolutionPSN52c62397-58f1-d34d-e063-6294a90a6faf1
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD52c62397-58f1-d34d-e063-6294a90a6faf1
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY52c62397-58f1-d34d-e063-6294a90a6faf1
311237ketotifen 0.025 % Ophthalmic SolutionSY52c62397-58f1-d34d-e063-6294a90a6faf1
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY52c62397-58f1-d34d-e063-6294a90a6faf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0522-1700000522011 BOTTLE in 1 CARTON (70000-0522-1) / 5 mL in 1 BOTTLE1 bottle2020-08-070000-00-00NoNoCurrent
70000-0522-2700000522021 BOTTLE in 1 CARTON (70000-0522-2) / 10 mL in 1 BOTTLE1 bottle2020-08-070000-00-00NoNoCurrent