CLARUS Antifungal

Product NDC
44577-470
11-digit product format
445770470
Labeler code
44577
Product ID
44577-470_126eb818-7e35-3cce-e063-6294a90a5e69
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-11
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLARUS Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-470-00CLARUS Antifungal1 in 1 BOXCREAM11
44577-470-00CLARUS Antifungal85 g in 1 TUBECREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-470CLARUS ANTIFUNGAL (TOLNAFTATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1Current NDC, 2 package rows20240312_835c3c23-fc3c-404e-8e87-5a0176126730.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN835c3c23-fc3c-404e-8e87-5a01761267301
103951tolnaftate 10 MG/ML Topical CreamSCD835c3c23-fc3c-404e-8e87-5a01761267301
103951tolnaftate 1 % Topical CreamSY835c3c23-fc3c-404e-8e87-5a01761267301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44577-470-00445770470001 TUBE in 1 BOX (44577-470-00) / 85 g in 1 TUBE1 tube2024-03-11NoNoCurrent