Tinea Versicolor Treatment Cream

Product NDC
85398-002
11-digit product format
853980002
Labeler code
85398
Product ID
85398-002_4c059bb0-15ad-ca94-e063-6294a90a4643
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-12
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
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
Tinea Versicolor Treatment Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

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
85398-002-01Tinea Versicolor Treatment Cream60 g in 1 TUBECREAM602
85398-002-01Tinea Versicolor Treatment Kit60 g in 1 TUBECREAM60 g10 mg in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85398-002TINEA VERSICOLOR TREATMENT CREAM (CLOTRIMAZOLE) CREAM [BEAUTIVITY LLC]1Current NDC, 1 package rows20250513_32d71d7e-3c78-6b63-e063-6294a90adaed.zip
85398-002TINEA VERSICOLOR TREATMENT KIT (CLOTRIMAZOLE) KIT [BEAUTIVITY LLC]1Current NDC20250515_3361d9a2-daf6-7749-e063-6294a90a3653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN3361d9a2-daf6-7749-e063-6294a90a36532
309367clotrimazole 1 % Topical CreamPSN32d71d7e-3c78-6b63-e063-6294a90adaed2
309367clotrimazole 1 % Topical CreamPSN3361d9a2-daf6-7749-e063-6294a90a36532
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD3361d9a2-daf6-7749-e063-6294a90a36532
309367clotrimazole 10 MG/ML Topical CreamSCD32d71d7e-3c78-6b63-e063-6294a90adaed2
309367clotrimazole 10 MG/ML Topical CreamSCD3361d9a2-daf6-7749-e063-6294a90a36532
251267clotrimazole 1 % Medicated Bar SoapSY3361d9a2-daf6-7749-e063-6294a90a36532
309367clotrimazole 1 % Topical CreamSY32d71d7e-3c78-6b63-e063-6294a90adaed2
309367clotrimazole 1 % Topical CreamSY3361d9a2-daf6-7749-e063-6294a90a36532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-002-018539800020160 g in 1 TUBE (85398-002-01) 60 g2025-05-12NoNoHistorical