FDA.reportPublic FDA data

Equate Eye Itch Relief

Product NDC
49035-231
11-digit product format
490350231
Labeler code
49035
Product ID
49035-231_23a94887-f625-4a01-bcda-131ca5286372
Type
HUMAN OTC DRUG
Nonproprietary name
ketotifen fumarate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Wal-Mart Stores, Inc.
Application
NDA021996
Marketing category
NDA
Marketing start
2016-01-01
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
Equate 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
49035-231-10Equate Eye Itch Relief1 in 1 CARTONSOLUTION13
49035-231-10Equate Eye Itch Relief10 mL in 1 BOTTLESOLUTION103
49035-231-11Equate Eye Itch Relief10 mL in 1 BOTTLESOLUTION103
49035-231-11Equate Eye Itch Relief2 in 1 CARTONSOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-231EQUATE EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION [WAL-MART STORES, INC.]3Current NDC, Legacy NDC, 4 package rows20210408_accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSNaccb5fe9-b3d0-4e2e-a3f0-e7d16873bbb93
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCDaccb5fe9-b3d0-4e2e-a3f0-e7d16873bbb93
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSYaccb5fe9-b3d0-4e2e-a3f0-e7d16873bbb93
311237ketotifen 0.025 % Ophthalmic SolutionSYaccb5fe9-b3d0-4e2e-a3f0-e7d16873bbb93
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSYaccb5fe9-b3d0-4e2e-a3f0-e7d16873bbb93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-231-10490350231101 BOTTLE in 1 CARTON (49035-231-10) / 10 mL in 1 BOTTLE1 bottle2016-01-010000-00-00NoNoCurrent
49035-231-11490350231112 BOTTLE in 1 CARTON (49035-231-11) / 10 mL in 1 BOTTLE2 bottle2018-07-020000-00-00NoNoCurrent