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 |
|---|---|---|---|---|---|---|
| Unishield Hand Sanitizer | ETHYL ALCOHOL | Unishield | eae1fc97-eb39-4353-adfa-7c549d50b5db | 2025-09-24 | Warnings | M005 |
| RUGBY ANTIFUNGAL CLOTRIMAZOLE | CLOTRIMAZOLE | Rugby Laboratories | 0b32a369-ea1c-4cb8-8ea1-07bba8f16b72 | 2025-09-16 | Warnings | M005 |
| SKIN TAG WART AND CORN REMOVER | SALICYLIC ACID | Zhenping Renren Industry Co., Ltd. | 3e6dad69-b301-f7dc-e063-6394a90ad380 | 2025-09-14 | Warnings | M005 |
| FUNGAL NAILS REPAIRING ESSENCE | PEPPERMINT OIL | Zhenping Renren Industry Co., Ltd. | 3e82649c-d784-d64c-e063-6294a90ac95d | 2025-09-11 | Warnings | M005 |
| equate Athletes Foot | TOLNAFTATE | Wal-Mart Stores Inc | e90297d0-0f87-4ae3-b9b7-959266d57c24 | 2025-09-11 | Warnings | M005 |
| Bee Venom Toenail Fungus Treatment | BEE VENOM TOENAIL FUNGUS TREATMENT | Shenzhen Earth Surface Trading Co., Ltd. | 3e7d22b0-2f57-fcac-e063-6394a90aefd9 | 2025-09-10 | Warnings | M005 |
| Amerfresh Antibacterial Deodorant | BENZETHONIUM CHLORIDE | Liufangjing Biotechnology (Yangzhou) Co., Ltd | cdc4f0ff-07bd-47c8-850b-1698308bb660 | 2025-09-09 | Warnings | M005 |
| Antifungal Cream | MICONAZOLE NITRATE | Encube Ethicals, Inc. | 8be4bbfa-424c-4ccf-b8bc-65b16c126053 | 2025-09-04 | Warnings | M005 |
| ANTIFUNGAL | CLOTRIMAZOLE | Encube Ethicals, Inc. | afbc28f8-bb76-424d-9d73-136e6c283ead | 2025-09-04 | Warnings | M005 |
| Hermon Balanitis relief kit | SULFUR 1X HPUS | Beautivity LLC | 3dce086e-a4eb-4b21-e063-6394a90aa1b2 | 2025-09-02 | Warnings | M005 |
| Extra Strength Nail Fungus Treatment | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3abc0892-e52b-a40f-e063-6294a90a0e35 | 2025-09-02 | Warnings | M005 |
| Hermon Balanitis Cream | SULFUR 1X HPUS | Beautivity LLC | 3dba4e4b-8224-6a96-e063-6394a90a9129 | 2025-09-01 | Warnings | M005 |
| Caseys | BENZALKONIUM CHLORIDE | Zhejiang Bright Care Co., Ltd. | a29d6c19-01aa-45b0-92cd-3f1148bad4f8 | 2025-08-30 | Warnings | M005 |
| Tolnafate | TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE | VALU MERCHANDISERS, CO. | 1d258684-9034-460c-953d-78e2b5198167 | 2025-08-26 | Warnings | M005 |
| Femmesil Maximum Strength | MICONAZOLE NITRATE | Aidance Skincare & Topical Solutions, LLC | d8b01fe1-4465-497b-909e-f51f31fdf833 | 2025-08-25 | Warnings | M005 |
| femmesil Ultra Therapy | CLOTRIMAZOLE | Aidance Scientific, Inc. | 3d36794a-07d0-860c-e063-6294a90a6e8f | 2025-08-25 | Warnings | M005 |
| Nedtol Folliculitis Treatment Creams | MICONAZOLE NITRATE | Jiashen International Trade Limited | 3d0a1e39-82e4-9337-e063-6294a90aa9a3 | 2025-08-23 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | TRIFECTA PHARMACEUTICALS USA LLC | 6b74d405-42d6-4c46-ba78-3007d1e8ffb8 | 2025-08-23 | Warnings | M005 |
| FUNGLARA Anti Fungal | UNDECYLENIC ACID | FUNGLARA LLC | a23c2399-36ea-4f22-8140-066e22c9a862 | 2025-08-20 | Warnings | M005 |
| Rapid MicroGel | TOLNAFTATE | The Tetra Corporation | afb6d7c4-1f75-4694-83c8-d6469250d6a1 | 2025-08-19 | 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 |