Tinea Versicolor Treatment Kit
- Product NDC
- 85398-004
- 11-digit product format
- 853980004
- Labeler code
- 85398
- Product ID
- 85398-004_5566dc99-c9bf-82de-e063-6294a90a45e5
- 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
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 Kit
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3361d9a2-daf6-7749-e063-6294a90a3653 | 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 |
|---|---|---|---|---|---|---|
| 85398-002-01 | Tinea Versicolor Treatment Kit | 60 g in 1 TUBE | CREAM | 60 g | 10 mg in 1g | 2 |
| 85398-003-01 | Tinea Versicolor Treatment Kit | 116 g in 1 CARTON | SOAP | 116 g | 1 g in 100g | 2 |
| 85398-004-01 | Tinea Versicolor Treatment Kit | 1 in 1 KIT | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Hongo Killer | UNDECYLENIC ACID | Efficient Laboratories Inc | 5c433182-0c0c-4a0a-8dd8-a14f60e52425 | 2024-10-14 | Warnings | M005 |
| Miconazole nitrate | ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY | Meijer Distribution Inc | 6c2ebe17-994d-41c8-bacb-87b6a63b2db4 | 2024-10-14 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL | McKesson | 8dcca44a-16c7-7262-e053-2a95a90a1b23 | 2024-10-10 | Warnings | M005 |
| CAREALL Clotrimazole | CLOTRIMAZOLE | New World Imports, Inc | ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a | 2024-10-07 | Warnings | M005 |
| Micotrin AL | TOLNAFTATE | PureTek Corporation | cc0fba1e-82c5-42fd-e053-2995a90af249 | 2024-10-02 | Warnings | M005 |
| Mycozyl AL | TOLNAFTATE | PureTek Corporation | b82c9a8a-f6f1-dca6-e053-2995a90a47f9 | 2024-10-02 | Warnings | M005 |
| MY MEDIC SUPER SANITIZER | ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | f19971b1-2aeb-4c37-82b0-9525026cff7a | 2024-10-02 | Warnings | M005 |
| Micotrin AC | CLOTRIMAZOLE | PureTek Corporation | cbe4dd18-c9ef-a4e4-e053-2995a90a5289 | 2024-10-01 | Warnings | M005 |
| Micotrin AP | MICONAZOLE NITRATE | PureTek Corporation | cbe3d495-cdee-2343-e053-2a95a90a5b82 | 2024-10-01 | Warnings | M005 |
| Mycozyl AC | CLOTRIMAZOLE | PureTek Corporation | b676d257-3cfd-7f24-e053-2995a90a546e | 2024-10-01 | Warnings | M005 |
| Mycozyl AP | MICONAZOLE NITRATE | PureTek Corporation | b3c46a30-7ff2-0dc4-e053-2995a90aa571 | 2024-10-01 | Warnings | M005 |
| AOSI HEALTHCARE HAND SANITIZER | ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 59d631d0-d8ae-45a8-a7a9-26de9cc427b3 | 2024-09-25 | Warnings | M005 |
| Clotrimazole 1% | CLOTRIMAZOLE | Dabur India Limited | 22916978-303f-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M005 |
| Mentholatum Heel Revival Cream | MENTHOLATUM HEEL REVIVAL CREAM | The Mentholatum Company | 21b643c2-eb6e-8939-e063-6394a90aaeac | 2024-09-09 | Warnings | M005 |
| VAGISTEN-V 7 DAY | MICONAZOLE NITRATE | OPMX LLC | a5bfa501-5ae1-4434-bc31-995d0665b99e | 2024-09-04 | Warnings | M005 |
| COTTON ON FOUNDATION Tropical Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 3645359c-06a2-4b97-b982-c54e4a0b8cda | 2024-09-04 | Warnings | M005 |
| COTTON ON FOUNDATION Coastal Hand Sanitizer | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | 645c09dc-15a4-481f-a605-f12fb8f8e9bd | 2024-09-04 | Warnings | M005 |
| Publix Athletic Foot | CLOTRIMAZOLE 1% | PUBLIX SUPER MARKETS, INC. | d9f99680-5636-4136-a7c6-c3643339e6b4 | 2024-08-02 | Warnings | M005 |
| ANTIFUNGAL FOOT | TOLNAFTATE | Universal Distribution Center LLC | 10579848-5793-4d72-ad5f-62d191c71074 | 2024-07-16 | Warnings | M005 |
| MY MEDIC SUPER SANITIZER | ETHYL ALCOHOL | Nantong Health & Beyond Hygienic Products Inc. | cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf3 | 2024-07-02 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | 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 | 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 |
|---|---|---|---|---|---|---|---|
| 85398-002-01 | 85398000201 | 60 g in 1 TUBE | 60 g | Historical | |||
| 85398-003-01 | 85398000301 | 116 g in 1 CARTON | 116 g | Historical | |||
| 85398-004-01 | 85398000401 | 1 KIT in 1 KIT (85398-004-01) * 60 g in 1 TUBE (85398-002-01) * 116 g in 1 CARTON (85398-003-01) | 1 kit | 2025-05-15 | No | No | Current |