Tinea Versicolor Treatment Kit

Product NDC
85398-004
11-digit product format
853980004
Labeler code
85398
Product ID
85398-004_4c068ebf-7025-056d-e063-6394a90af53f
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
KIT
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-15
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 Kit
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui251267, 309367

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 Kit60 g in 1 TUBECREAM60 g10 mg in 1g2
85398-003-01Tinea Versicolor Treatment Kit116 g in 1 CARTONSOAP116 g1 g in 100g2
85398-004-01Tinea Versicolor Treatment Kit1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85398-004TINEA VERSICOLOR TREATMENT KIT (CLOTRIMAZOLE) KIT [BEAUTIVITY LLC]1Current NDC, 3 package rows20250515_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 CreamPSN3361d9a2-daf6-7749-e063-6294a90a36532
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD3361d9a2-daf6-7749-e063-6294a90a36532
309367clotrimazole 10 MG/ML Topical CreamSCD3361d9a2-daf6-7749-e063-6294a90a36532
251267clotrimazole 1 % Medicated Bar SoapSY3361d9a2-daf6-7749-e063-6294a90a36532
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 TUBE60 gHistorical
85398-003-0185398000301116 g in 1 CARTON116 gHistorical
85398-004-01853980004011 KIT in 1 KIT (85398-004-01) * 60 g in 1 TUBE (85398-002-01) * 116 g in 1 CARTON (85398-003-01) 1 kit2025-05-15NoNoCurrent