Eye Itch Releif

Product NDC
11822-5533
11-digit product format
118225533
Labeler code
11822
Product ID
11822-5533_1ddd5a87-3863-532b-e063-6394a90ab8bf
Type
HUMAN OTC DRUG
Nonproprietary name
Ketotifen Fumarate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rite Aid Corporation
Application
NDA021996
Marketing category
NDA
Marketing start
2022-04-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eye Itch Releif
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
11822-5533-1Eye Itch Releif10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
11822-5533-1Eye Itch Releif1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5533EYE ITCH RELEIF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240724_6a7be1e9-27ff-44d8-85ed-fc1b0017180e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN6a7be1e9-27ff-44d8-85ed-fc1b0017180e3
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD6a7be1e9-27ff-44d8-85ed-fc1b0017180e3
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY6a7be1e9-27ff-44d8-85ed-fc1b0017180e3
311237ketotifen 0.025 % Ophthalmic SolutionSY6a7be1e9-27ff-44d8-85ed-fc1b0017180e3
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY6a7be1e9-27ff-44d8-85ed-fc1b0017180e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-5533-1118225533011 BOTTLE, DROPPER in 1 CARTON (11822-5533-1) / 10 mL in 1 BOTTLE, DROPPER2022-04-010000-00-00NoNoCurrent