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 |
|---|---|---|---|---|---|---|
| Dr. Rainer s Vaginal Cream | MICONAZOLE NITRATE | Plexoris Health Care Products, Llc | 1f0ee635-c70d-4194-a01d-370ca5c22fcd | 2024-12-11 | Warnings | M005 |
| BOA VIDA Antifungal | MICONAZOLE NITRATE | Central Solutions Inc | 69c5340d-9abd-43bf-a90b-9568d615f06f | 2024-12-09 | Warnings | M005 |
| BLUESEA DISPOSABLE HAND SANITIZER | ALCOHOL | BLUE SEA AEROSOL & DAILY CARE CO., LTD | 7a552be2-a9e1-4c6f-b1c2-79113a73bd2f | 2024-12-06 | Warnings | M005 |
| U HAND SANITIZER CLASSIC | BENZALKONIUM CHLORIDE | BLUE SEA AEROSOL & DAILY CARE CO., LTD | fbc27a24-0e81-4907-b24f-881c4fe0ec44 | 2024-12-06 | Warnings | M005 |
| BLUESEA INSTANT HAND SANITIZER | ALCOHOL | BLUE SEA AEROSOL & DAILY CARE CO., LTD | e6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd | 2024-12-06 | Warnings | M005 |
| Povidone-Iodine | POVIDONE-IODINE | Mazza Healthcare, LLC | 31df570a-35ae-41a2-b04a-fce65e9d596d | 2024-11-21 | Warnings | M005 |
| Povidone-Iodine | POVIDONE-IODINE | Mazza Healthcare, LLC | 3dc3303f-54b2-4aec-8568-5e0f8eb7cb14 | 2024-11-21 | Warnings | M005 |
| WINCO ANTIFUNGAL | TOLNAFTATE 1% | WinCo Foods LLC | 46b58c71-d62e-4b3d-b2ec-65407032eeea | 2024-11-21 | Warnings | M005 |
| Dynarex Antifungal | ANTIFUNGAL | Dynarex Corporation | ab5b6467-c158-4407-9d52-3c0731030680 | 2024-11-20 | Warnings | M005 |
| Terrasil JockItch Treatment Maximum Strength | CLOTRIMAZOLE | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 8afe11c1-0a85-4255-8eba-e8cbde0759a0 | 2024-11-20 | Warnings | M005 |
| Terrasil Ringworm Treatment MAX | CLOTRIMAZOLE | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | fc2b740a-49c1-4a01-a94c-8cade52a2b82 | 2024-11-20 | Warnings | M005 |
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | ALLIED TRADE LINK LLC | 25520dba-0159-2a3f-e063-6294a90a4c33 | 2024-11-12 | Warnings | M005 |
| CLOTRIMAZOLE | CLOTRIMAZOLE | ALLIED TRADE LINK LLC | 266d7b94-2954-4831-e063-6394a90a3f33 | 2024-11-08 | Warnings | M005 |
| Antifungal | TOLNAFTATE 1% | Chain Drug Marketing Association Inc. | 26303499-dc58-f417-e063-6394a90a0a1b | 2024-11-05 | Warnings | M005 |
| AZOLEN | MICONAZOLE NITRATE | STRATUS PHARMACEUTICALS INC | 3264bd0a-c628-404b-8c09-8586682d054e | 2024-10-31 | Warnings | M005 |
| BACITRACIN ZINC | BACITRACIN ZINC | STRATUS PHARMACEUTICALS INC | b2cb3a96-b0ca-42ee-8056-91d5450fb376 | 2024-10-31 | Warnings | M005 |
| Premier Value Antifungal Maximum Strength | UNDECYLENIC ACID | PHARMACY VALUE ALLIANCE, LLC | f5694ee5-616c-40f6-8da4-c3620dbcd6f7 | 2024-10-28 | Warnings | M005 |
| Clotrimazole 1% | CLOTRIMAZOLE | Chain Drug Marketing Association Inc. | 24ff5ad7-2ff9-b254-e063-6394a90a27a7 | 2024-10-21 | Warnings | M005 |
| Micomitin Antifungal | TOLNAFTATE | PureTek Corporation | de9842ba-0254-8ae1-e053-2995a90a0664 | 2024-10-16 | Warnings | M005 |
| Ongo - Fin | TOLNAFTATE | Efficient Laboratories Inc. | bb5fb71f-bee0-42fa-9c9f-6231b555324c | 2024-10-14 | 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 |