FDA.reportPublic FDA data

Eye Itch Relief

Product NDC
0363-0038
11-digit product format
003630038
Labeler code
0363
Product ID
0363-0038_4ddfb3f8-812d-c7c4-e063-6394a90a284d
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Walgreen Company
Application
NDA021996
Marketing category
NDA
Marketing start
2013-09-03
Substance
KETOTIFEN FUMARATE
Active strength
.35 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.35 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
0363-0038-05Eye Itch Relief1 in 1 CARTONSOLUTION19
0363-0038-05Eye Itch Relief5 mL in 1 BOTTLESOLUTION59
0363-0038-10Eye Itch Relief1 in 1 CARTONSOLUTION19
0363-0038-10Eye Itch Relief10 mL in 1 BOTTLESOLUTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0038EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [WALGREEN COMPANY]7Current NDC, Legacy NDC, 4 package rows20240322_9ce8f926-c202-40d1-9dba-0477f1f49e14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN9ce8f926-c202-40d1-9dba-0477f1f49e149
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD9ce8f926-c202-40d1-9dba-0477f1f49e149
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY9ce8f926-c202-40d1-9dba-0477f1f49e149
311237ketotifen 0.025 % Ophthalmic SolutionSY9ce8f926-c202-40d1-9dba-0477f1f49e149
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY9ce8f926-c202-40d1-9dba-0477f1f49e149

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0038-05003630038051 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE1 bottle2013-09-030000-00-00NoNoCurrent
0363-0038-10003630038101 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE1 bottle2013-09-030000-00-00NoNoCurrent