Fungicure Manicure Pedicure Liquid Gel
- Product NDC
- 52389-647
- 11-digit product format
- 523890647
- Labeler code
- 52389
- Product ID
- 52389-647_ec80d838-11a9-c815-e053-2995a90a204b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alva-Amco Pharmacal Companies, Inc.
- Application
- M005
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2016-07-05
- Marketing end
- 0000-00-00
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52389-647 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 52389-647 | 52389-647-09 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 52389-647 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52389-647 | 52389-647-09 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 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 |
|---|---|---|---|---|---|---|
| Clotrimazole | DRS. CLOTRIMAZOLE | OL PHARMA TECH,LLC | b0e9fc77-6d5c-2472-e053-2995a90a3de4 | 2025-01-09 | Warnings | M005 |
| Anti-Bacterial Wipes | BENZALKONIUM CHLORIDE | Tongling Jieya Biological Technology Co., Ltd. | d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d | 2025-01-04 | Warnings | M005 |
| AVON HeXashield Athletes Foot Cream | TOLNAFTATE | Tai Guk Pharm. Co., Ltd. | 8f2b6a09-8cb0-0d17-e053-2995a90aa07f | 2025-01-01 | Warnings | M005 |
| Tolnaftate | TOLNAFTATE 1% | Trifecta Pharmaceuticals USA, LLC | 091b907f-544a-86c9-e063-6294a90a5d87 | 2024-12-31 | Warnings | M005 |
| terrasil Fungal Treatment | CLOTRIMAZOLE | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 278290f9-be14-81a8-e063-6294a90ad8cc | 2024-12-26 | Warnings | M005 |
| DEO PEDICO ABOVE NEYMAR JR MEN | DEO PEDICO ABOVE NEYMAR JR MEN | BASTON INDUSTRIA DE AEROSSOIS LTDA | ed4a9844-f20b-da5d-e053-2995a90adc09 | 2024-12-26 | Warnings | M005 |
| Vite20 | MICONAZOLE NITRATE | Blaine Labs Inc. | 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71 | 2024-12-24 | Warnings | M005 |
| Vite20 | UNDECYLENIC ACID | Blaine Labs Inc. | 18f8ea1c-360e-43c0-98df-5816af4dec66 | 2024-12-24 | Warnings | M005 |
| Tolnaftate Cream 1% ANTIFUNGAL | FAMILY WELLNESS TOLNAFTATE | Trifecta Pharmaceuticals USA, LLC | 915759af-0d7f-6a87-e053-2a95a90acbd6 | 2024-12-20 | Warnings | M005 |
| Rugby Clotrimazole Antifungal Cream | CLOTRIMAZOLE | Rugby Laboratories | a1365bc7-b376-adca-e053-2a95a90acf19 | 2024-12-20 | Warnings | M005 |
| Miconazole Nitrate | ANTIFUNGAL MICONAZOLE POWDER SPRAY | Premier Brands of America Inc. | dc7a23bb-b246-89b1-e053-2995a90a9f2d | 2024-12-20 | Warnings | M005 |
| Warrior Antifungal Foot | MICONAZOLE NITRATE 2% | Derma Care Research Labs, LLC | cf2e9dc1-275b-4454-e053-2995a90af295 | 2024-12-20 | Warnings | M005 |
| Tolnaftate Cream 1% | TOLNAFTATE | Pharmacy Value Alliance, LLC. | 3abfd734-229b-1a0e-e054-00144ff88e88 | 2024-12-20 | Warnings | M005 |
| Dermatool Fungal Nail Treatment | TOLNAFTATE 1% | Derma Care Research Labs, LLC | fbc1a55e-b994-4962-e053-6394a90a13ba | 2024-12-19 | Warnings | M005 |
| Novonail Solution | TOLNAFTATE 1% | Derma Care Research Labs, LLC | 013d6107-e3b0-0264-e063-6394a90ae1e2 | 2024-12-19 | Warnings | M005 |
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | Rugby | f420de00-408f-9a2c-e053-2995a90adced | 2024-12-17 | Warnings | M005 |
| Relispray Antifungal Liquid | TOLNAFTATE | Midas-Care Pharmaceuticals Pvt. Ltd. | 6522ad59-f810-408c-a9f9-9359d79302ce | 2024-12-17 | Warnings | M005 |
| Clotrimazole | FAMILY WELLNESS CLOTRIMAZOLE | Trifecta Pharmaceuticals USA LLC | 915759af-0d7b-6a87-e053-2a95a90acbd6 | 2024-12-13 | Warnings | M005 |
| Blistex Odor-Eaters Powder | TOLNAFTATE | Blistex Inc | 819edb2f-dda7-45c3-b0da-ebcae354154e | 2024-12-12 | Warnings | M005 |
| Walgreens Athletes Foot | TOLNAFTATE SPRAY | Walgreens | c68ad65d-b016-0069-e053-2995a90ae7ef | 2024-12-11 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52389-647-09 | 52389064709 | 1 TUBE, WITH APPLICATOR in 1 BOX (52389-647-09) > 9 g in 1 TUBE, WITH APPLICATOR | 2016-07-06 | 0000-00-00 | No | No | Current |