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 | 2026-10-15 | ||
| excluded package | package | 52389-647 | 52389-647-09 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Athletes Foot | MICONAZOLE NITRATE | Premier Brands of America Inc | 52d0909a-f404-0af4-e063-6394a90a3d0c | 2026-06-01 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 431483f6-2386-9f5c-e063-6294a90af104 | 2026-06-01 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Walgreens Company | 3f8d45e1-54a2-a658-e063-6294a90a6cbb | 2026-06-01 | Warnings | M005 |
| Remedy Nails | UNDECYLENIC ACID | Adwill Labs Inc | 4e87b76c-c430-466a-bc30-fe1785c7c660 | 2026-06-01 | Warnings | M005 |
| Anytalk Nail Fungus Treatment 15ml (1% Tonailate) | TOLNAFTATE1% | Guangzhou Huixue Biotechnology Co., Ltd. | 52f1f654-fba3-e90e-e063-6394a90a1df4 | 2026-05-29 | Warnings | M005 |
| RoyceDerm Tea Tree Oil Antifungal .spray. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 52da8be4-467c-c011-e063-6294a90a166f | 2026-05-28 | Warnings | M005 |
| Terramed Just Think Comfort Jock Itch Antifungal Treatment | MICONAZOLE NITRATE | Rida LLC | 2acb9027-8f20-4b77-9b45-17fe11622c7c | 2026-05-27 | Warnings | M005 |
| Quali Life ANTIFUNGAL TEA TREE | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 52b3b0df-3f62-f9bc-e063-6394a90a52b3 | 2026-05-26 | Warnings | M005 |
| ANTIFUNGAL PEN | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b51877-e04c-569e-e063-6394a90a2fc9 | 2026-05-26 | Warnings | M005 |
| NAIL EXTRA STRENGTH REPAIR PEN | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b6208d-53e4-eaa0-e063-6394a90abe7a | 2026-05-26 | Warnings | M005 |
| Toenail Fungus Pen Preventative | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b6766f-948b-2602-e063-6294a90a03cf | 2026-05-26 | Warnings | M005 |
| KDMAN | TOLNAFTATE | Dongguan Youmi Trading Co., Ltd | 52a4e836-2059-a49f-e063-6394a90a6556 | 2026-05-25 | Warnings | M005 |
| PUTRIZEN | UNDECYLENIC ACID, TOLNAFTATE | Guangzhou Lianbiquan Biological Technology co., Ltd | 52a58f24-2a11-4d34-e063-6394a90a2924 | 2026-05-25 | Warnings | M005 |
| Eye CareSpray | EYELID CLEANSING SPRAY | Shenzhen Shierjie Biological Engineering Co., LTD | 52aef5dd-ff33-cace-e063-6294a90a415a | 2026-05-25 | Warnings | M005 |
| Saviland PRO Extra Strength Toenail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 5250003a-8d3a-818b-e063-6294a90aa659 | 2026-05-21 | Warnings | M005 |
| Saviland SSPro X Series Extra Strength Toenail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52506297-44d7-b2a7-e063-6394a90a0a3c | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52512e7e-5e28-4383-e063-6294a90a448a | 2026-05-21 | Warnings | M005 |
| Vrenmol Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52516861-e386-d0cb-e063-6394a90a17d0 | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Toenail Renewal Solution | TOLNAFTATE,UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52519110-a3c9-21da-e063-6294a90abbce | 2026-05-21 | Warnings | M005 |
| Fungal Nail Repair Pen | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 523c32f7-b803-bf79-e063-6394a90aad5a | 2026-05-20 | 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 |