Fortinia OF

Product NDC
54633-017
11-digit product format
546330017
Labeler code
54633
Product ID
54633-017_47e362c2-c357-adbe-e063-6294a90a6043
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
2017-07-05
Substance
CLOTRIMAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fortinia OF
Listing expiration
2027-12-31

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
54633-017-01Fortinia OF29.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54633-017FORTINIA OF (CLOTRIMAZOLE 1%) SOLUTION [THE PODIATREE COMPANY]2Current NDC, Legacy NDC, 1 package rows20171221_60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f3
309370clotrimazole 10 MG/ML Topical SolutionSCD60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f3
309370clotrimazole 1 % Topical SolutionSY60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54633-017-015463300170129.57 mL in 1 BOTTLE, GLASS (54633-017-01) 29.57 ml2017-07-050000-00-00NoNoCurrent