Tinea Versicolor Treatment Bar
- Product NDC
- 85398-003
- 11-digit product format
- 853980003
- Labeler code
- 85398
- Product ID
- 85398-003_4c063f20-6beb-045a-e063-6394a90a2f46
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- SOAP
- 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 Bar
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Rxcui | 251267 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85398-003-01 | Tinea Versicolor Treatment Kit | 116 g in 1 CARTON | SOAP | 116 g | 1 g in 100g | 2 |
| 85398-003-01 | Tinea Versicolor Treatment Bar | 116 g in 1 CARTON | SOAP | 116 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85398-003 | TINEA VERSICOLOR TREATMENT BAR (CLOTRIMAZOLE) SOAP [BEAUTIVITY LLC] | 1 | Current NDC, 1 package rows | 20250513_33612382-2f12-e9f6-e063-6394a90aaee4.zip |
| 85398-003 | TINEA VERSICOLOR TREATMENT KIT (CLOTRIMAZOLE) KIT [BEAUTIVITY LLC] | 1 | Current NDC | 20250515_3361d9a2-daf6-7749-e063-6294a90a3653.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85398-003-01 | 85398000301 | 116 g in 1 CARTON (85398-003-01) | 116 g | 2025-05-12 | No | No | Current |