Tinea Versicolor Treatment Bar
- Product NDC
- 85398-003
- 11-digit product format
- 853980003
- Labeler code
- 85398
- Product ID
- 85398-003_5566dc99-c9b2-82de-e063-6294a90a45e5
- 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tinea Versicolor Treatment Bar
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOTRIMAZOLE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G07GZ97H65 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 251267 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 33612382-2f12-e9f6-e063-6394a90aaee4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 | 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Velloryn ANTIFUNGAL Cream | ZINC UNDECYLENATE, UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4e38e1f1-0466-5b91-e063-6294a90a66c4 | 2026-03-30 | Warnings | M005 |
| APUREE Nailtific Extra-Max Strength Daytime Antigungal | APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 4e3d226b-57f1-75a6-e063-6394a90a96cd | 2026-03-30 | Warnings | M005 |
| APUREE Nailtific Extra-Max Strength Nighttime Antifungal | APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 4e3e8895-34b4-de69-e063-6294a90a5532 | 2026-03-30 | M005 | |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | CVS Pharmacy | 3380263d-ee7b-4946-a467-35a24789a901 | 2026-03-27 | Warnings | M005 |
| Micro-Guard (AF) | MICONAZOLE NITRATE | Coloplast Corp | a43a94d0-fec0-470f-bdb4-535dcce6d1e0 | 2026-03-27 | Warnings | M005 |
| Suave Antibacterial Hand Wash Fresh Citrus | LIQUID HAND WASH ANTIBACTERIAL | Suave Brands Co, LLC | 41d77ec6-a1d1-13dc-e063-6394a90a95f4 | 2026-03-26 | Warnings | M005 |
| Suave Antibacterial Hand Wash Deeply Clean | LIQUID HAND WASH ANTIBACTERIAL | Suave Brands Co, LLC | 41d83736-66da-abb9-e063-6294a90a3d67 | 2026-03-26 | Warnings | M005 |
| Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera | LIQUID HAND WASH ANTIBACTERIAL | Suave Brands Co, LLC | 41d8848c-d157-6e2c-e063-6294a90aa259 | 2026-03-26 | Warnings | M005 |
| Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch | ANTIFUNGAL TREATMENT KIT | Beautivity LLC | 4800a93b-7042-827b-e063-6294a90acd95 | 2026-03-25 | Warnings | M005 |
| Toenail Fungus Treatment | TERBINAFINE | Shenzhen Wankelai E-commerce Co., Ltd. | 4dc1d7f7-e4ae-c54b-e063-6394a90aa420 | 2026-03-24 | Warnings | M005 |
| Lasolex Liquid Solution | CLOTRIMAZOLE 1% | PureTek Corporation | 4dc9e64d-8235-b218-e063-6394a90a0157 | 2026-03-24 | Warnings | M005 |
| Hermon Jock Itch Antifungal Treatment .Soap. Bar | TOLNAFTATE 1% | Beautivity LLC | 4dbbf09b-5bc1-501b-e063-6394a90a2a9d | 2026-03-23 | Warnings | M005 |
| Hermon Jock Itch Antifungal Treatment Cream | MICONAZOLE NITRATE 2% | Beautivity LLC | 4dbc521c-2f5f-9736-e063-6294a90ad85d | 2026-03-23 | Warnings | M005 |
| seebeellar clotrimazole 1% antifungal cream | SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 4d80e551-76c2-150a-e063-6394a90a7996 | 2026-03-20 | Warnings | M005 |
| Nail Fungal Pen | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 4d5b5c22-4781-6391-e063-6294a90a7010 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MADRID MUSE | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5cecf6-c232-6cd9-e063-6394a90a03e9 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER VALENCIA VIBES | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5de4d6-4c58-f393-e063-6294a90a323a | 2026-03-19 | Warnings | M005 |
| Toenail Fungus Pen | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 4d5e256f-7fd5-f903-e063-6394a90a1160 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MALLORCA BREEZE | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5e50de-62fd-f9e9-e063-6394a90af0bd | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MAR BELLA | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d6005d9-5d4d-033e-e063-6294a90ad36f | 2026-03-19 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 251267 | clotrimazole 1 % Medicated Bar Soap | PSN | 33612382-2f12-e9f6-e063-6394a90aaee4 | 2 |
| 251267 | clotrimazole 1 % Medicated Bar Soap | PSN | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2 |
| 309367 | clotrimazole 1 % Topical Cream | PSN | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2 |
| 251267 | clotrimazole 0.01 MG/MG Medicated Bar Soap | SCD | 33612382-2f12-e9f6-e063-6394a90aaee4 | 2 |
| 251267 | clotrimazole 0.01 MG/MG Medicated Bar Soap | SCD | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2 |
| 309367 | clotrimazole 10 MG/ML Topical Cream | SCD | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2 |
| 251267 | clotrimazole 1 % Medicated Bar Soap | SY | 33612382-2f12-e9f6-e063-6394a90aaee4 | 2 |
| 251267 | clotrimazole 1 % Medicated Bar Soap | SY | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2 |
| 309367 | clotrimazole 1 % Topical Cream | SY | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2 |
Packages#
| 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 |