Fortinia Ultra

Product NDC
54633-025
11-digit product format
546330025
Labeler code
54633
Product ID
54633-025_43065a59-fb82-b1c2-e063-6294a90a36e0
Type
HUMAN OTC DRUG
Nonproprietary name
clotrimazole 1%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
The Podiatree Company
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-10
Substance
CLOTRIMAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fortinia Ultra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309370

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-025-15Fortinia Ultra15 mL in 1 BOTTLE, DROPPERSOLUTION152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN43065a59-fb81-b1c2-e063-6294a90a36e02
309370clotrimazole 10 MG/ML Topical SolutionSCD43065a59-fb81-b1c2-e063-6294a90a36e02
309370clotrimazole 1 % Topical SolutionSY43065a59-fb81-b1c2-e063-6294a90a36e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54633-025-155463300251515 mL in 1 BOTTLE, DROPPER (54633-025-15) 15 ml2025-12-01NoNoCurrent