Eye Itch Relief

Product NDC
69842-275
11-digit product format
698420275
Labeler code
69842
Product ID
69842-275_487284c4-cd56-cd13-e063-6394a90a3e06
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CVS Pharmacy
Application
NDA021996
Marketing category
NDA
Marketing start
2020-04-01
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
69842-275-05Eye Itch Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53
69842-275-05Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS13
69842-275-10Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS13
69842-275-10Eye Itch Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
69842-275-20Eye Itch Relief2 in 1 CARTONSOLUTION/ DROPS23
69842-275-20Eye Itch Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-275EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [CVS PHARMACY]2Current NDC, Legacy NDC, 6 package rows20201216_7d0146a9-5073-4e24-954f-75b84affadc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN7d0146a9-5073-4e24-954f-75b84affadc23
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD7d0146a9-5073-4e24-954f-75b84affadc23
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY7d0146a9-5073-4e24-954f-75b84affadc23
311237ketotifen 0.025 % Ophthalmic SolutionSY7d0146a9-5073-4e24-954f-75b84affadc23
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY7d0146a9-5073-4e24-954f-75b84affadc23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-275-05698420275051 BOTTLE, DROPPER in 1 CARTON (69842-275-05) / 5 mL in 1 BOTTLE, DROPPER2020-04-010000-00-00NoNoCurrent
69842-275-10698420275101 BOTTLE, DROPPER in 1 CARTON (69842-275-10) / 10 mL in 1 BOTTLE, DROPPER2020-04-010000-00-00NoNoCurrent
69842-275-20698420275202 BOTTLE, DROPPER in 1 CARTON (69842-275-20) / 10 mL in 1 BOTTLE, DROPPER2020-04-010000-00-00NoNoCurrent