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 |
|---|---|---|---|---|---|---|
| Triple Antifungal | MICONAZOLE NITRATE | Advantice Health, LLC | 9a47fb1b-a41f-4c8a-8e43-7332853c308e | 2026-03-19 | Warnings | M005 |
| Antifungal | CLOTRIMAZOLE | Dynarex Corporation | 4d4cc4b4-c0b4-9e25-e063-6294a90a70b8 | 2026-03-18 | Warnings | M005 |
| Antifungal | MICONAZOLE NITRATE | Dynarex Corporation | 4d384385-f3c5-09ba-e063-6394a90aec7f | 2026-03-17 | Warnings | M005 |
| Fungi Nail Toe and Foot | TOLNAFTATE | Kramer Laboratories | e21ccb83-54ff-4605-80bf-7b4b789c7cb7 | 2026-03-17 | Warnings | M005 |
| Peunitory Fungal Nail Treatment | TOLNAFTATE 1% | Guangzhou Huixue Biotechnology Co., Ltd. | 4d2e86bc-5122-ba4a-e063-6394a90acf13 | 2026-03-16 | Warnings | M005 |
| DRMITSUI FOOT ANTIFUNGAL TREATMENT | SALICYLIC ACID | Zhenping Renren Industry Co., Ltd. | 4ce59d31-56fe-d74f-e063-6294a90a7cce | 2026-03-14 | Warnings | M005 |
| NERANTE FUNGUS NAIL PEN | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3984b-53cd-a665-e063-6394a90afe5f | 2026-03-13 | Warnings | M005 |
| FUNGAL NAIL TREATMENT | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ce3f0e2-b532-b89f-e063-6294a90a7e25 | 2026-03-13 | Warnings | M005 |
| BYT BANGYTONG HELPS WITH NAGELPILZ | TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID | Shenzhen Jindali Technology Co., Ltd | 49ed1cc8-e8e5-399c-e063-6394a90a044a | 2026-03-10 | Warnings | M005 |
| Natouch Antifungal Wipes Plus | ANTIFUNGAL ANTISEPTIC WIPES PLUS | Natouch LLC | a85cb307-b3ad-1584-e053-2995a90a9a70 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb6fdfd-116e-14e9-e063-6294a90a4de3 | 2026-03-10 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b | 2026-03-10 | Warnings | M005 |
| SootheSense Toenail Fungus Treatment | UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4ca2bbeb-3b8a-9482-e063-6294a90a5789 | 2026-03-09 | Warnings | M005 |
| Natouch Antifungal Antiseptic Wipes | ANTIFUNGAL ANTISEPTIC WIPES | Natouch LLC | 4c84c556-8d0b-ec28-e063-6294a90af1d3 | 2026-03-08 | Warnings | M005 |
| ANTIFUNGAL Cream | ANGELICA DAHURICA EXTRACTT, ASIATIC ACID | Guangzhou Mizi Biotechnology Co., LTD. | 4c586cd9-d356-34d8-e063-6294a90a4d11 | 2026-03-06 | Warnings | M005 |
| FungiFoam | TOLNAFTATE | The Tetra Corporation | 2449e8e5-9d7e-4119-9e7a-378efe55f875 | 2026-03-06 | Warnings | M005 |
| RoyceDerm ANTIFUNGAL .soap. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 4c43e62b-9060-8962-e063-6394a90aff63 | 2026-03-05 | Warnings | M005 |
| Derman Antifungal | TOLNAFTATE | Compania Internacional de Comercio, S.A.P.I. de C.V. | 5784a783-1056-4d50-8d87-2df4f8e16b09 | 2026-03-05 | Warnings | M005 |
| Antifungal Powder | TOLNAFTATE | ARMY & AIR FORCE EXCHANGE SERVICE | 4c39e121-4919-a482-e063-6294a90a98cd | 2026-03-04 | Warnings | M005 |
| ViLLsure Antifungal Pen | UNDECYLENIC ACID 25%ANTIFUNGAL PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c28cf04-94ad-8db6-e063-6394a90a2eed | 2026-03-03 | 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 |