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 |
|---|---|---|---|---|---|---|
| MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | MICONAZOLE NITRATE | ASTONEA LABS PRIVATE LIMITED | e66191a6-0c3c-7319-e053-2a95a90aae84 | 2024-06-25 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | b63a3fe5-5684-41bc-ad6c-69c54e5b942d | 2024-06-20 | Warnings | M005 |
| THERA Antifungal Body | MICONAZOLE NITRATE | McKesson Medical-Surgical Inc. | 31096041-28c9-4b16-bbd1-dbadefd37505 | 2024-06-14 | Warnings | M005 |
| Antifungal Body | MICONAZOLE NITRATE | McKesson | 4fb9aece-0baa-475e-e054-00144ff8d46c | 2024-06-13 | Warnings | M005 |
| Secura Protective | ZINC OXIDE | Smith & Nephew Medical Ltd | b077aa64-49a3-42ee-abb3-88f833635b93 | 2024-06-12 | Warnings | M005 |
| clotrimazole | CLOTRIMAZOLE | NuCare Pharmaceuticals,Inc. | 627375fb-2f20-16bc-e053-2a91aa0a1542 | 2024-06-06 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Cardinal Health 110 dba LEADER | 199df107-3384-6e03-e063-6294a90afc38 | 2024-05-29 | Warnings | M005 |
| Femmesil | CLOTRIMAZOLE | Aidance Skincare & Topical Solutions, LLC | efddad82-9dc7-4cd9-b33c-7e85f30d992e | 2024-05-24 | Warnings | M005 |
| Anti-Fungal | MICONAZOLE NITRATE | Universal Distribution Center LLC | 8f316b0d-d308-4ae6-82c4-39bb0d1d474e | 2024-05-21 | Warnings | M005 |
| CANESPIES | TOLNAFTATE | OPMX LLC | e2f9eedc-3c43-416b-85b5-ba07fb5fb4db | 2024-05-17 | Warnings | M005 |
| Up and Up Antifungal | TOLNAFTATE 1% | Target Corporation | 8f54c8c7-6771-49c3-b429-53aa6df54dc5 | 2024-05-08 | Warnings | M005 |
| Up and Up Athletes Foot | CLOTRIMAZOLE 1% | Target Corporation | 52b61859-11ae-4990-aa0c-9dc1dd00adf4 | 2024-05-08 | Warnings | M005 |
| ADI Medical PVP-I Pouch, Foil | POVIDONE-IODINE | Asia Dynamics Inc., d/b/a ADI Medical | 0e8baf24-0c67-5511-e063-6394a90acaa1 | 2024-05-02 | Warnings | M005 |
| Caseys Antimicrobial Hand Sanitizer | ETHYL ALCOHOL | Navajo Manufacturing Company Inc. | 78863024-390c-4ff9-8ed6-02af07902a30 | 2024-04-29 | Warnings | M005 |
| MQUPIN Liquid Fungal Nail Treatment | LIQUID FUNGAL NAIL TREATMENT | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 14782f8c-3b29-1d88-e063-6294a90ac3e4 | 2024-03-25 | Warnings | M005 |
| ETADERM Advanced Antifungal Support | UNDECYLENIC ACID | NUEPHASE LLC | adb12a1c-ece9-4a59-a62c-89d212c57e6f | 2024-03-13 | Warnings | M005 |
| Dermachange Jock | MICONAZOLE NITRATE | Private label Beauty and Wellness | 12eef049-76c9-1450-e063-6394a90a00ea | 2024-03-05 | Warnings | M005 |
| Clotrimazole Antifungal | CLOTRIMAZOLE | Trifecta Pharmaceuticals USA, LLC. | 11bf50db-552e-0a39-e063-6394a90af60d | 2024-02-19 | Warnings | M005 |
| TOLNAFTATE ANTIFUNGAL | TOLNAFTATE | Bryant Ranch Prepack | fbbd159c-217e-46d3-963c-ba0bd1e9bbe8 | 2024-01-29 | Warnings | M005 |
| Target Jock Itch | CLOTRIMAZOLE 1% | Target Corporation | f44d4c44-99d1-413f-b9c3-8330bdd21abb | 2024-01-17 | 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 |