ANTIFUNGAL
ANTIFUNGAL is an FDA drug label for the active ingredient MICONAZOLE manufactured by VIVE HEALTH LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260701.
- Generic name
- MICONAZOLE
- Manufacturer
- VIVE HEALTH LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 84722-3057
- Application
- M005
- Label effective
- 20260701
About this product
ANTIFUNGAL is an FDA-registered drug product whose active ingredient is MICONAZOLE. It is labelled by VIVE HEALTH LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84722-3057, application M005, label effective 20260701. It is one of 5 FDA drug label records sharing the active ingredient MICONAZOLE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
Active ingredients
Indications & Usage
Indications and Usage
Dosage & Administration
Dosage
Warnings
Warnings
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View labelHow products containing MICONAZOLE compare
FDA lists 5 drug label records with MICONAZOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Nabrace LLC | 2 |
| — | — | Natouch LLC | 1 |
| — | — | Unifirst First Aid Corporation | 1 |
| — | — | VIVE HEALTH LLC | 1 |
| — | — | — | — |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0696-2026 | vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2. | Blaine Labs Inc | Class II | Ongoing | 20260708 |
| D-0698-2026 | Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc | Blaine Labs Inc | Class II | Ongoing | 20260708 |
| D-0697-2026 | TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 | Blaine Labs Inc | Class II | Ongoing | 20260708 |
| D-0694-2026 | TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01. | Blaine Labs Inc | Class II | Ongoing | 20260708 |
| D-0695-2026 | TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. | Blaine Labs Inc | Class II | Ongoing | 20260708 |
Frequently asked questions
What is ANTIFUNGAL used for?
Indications and Usage
Who makes ANTIFUNGAL?
VIVE HEALTH LLC is the labeler of record for ANTIFUNGAL. 5 FDA label records share the active ingredient MICONAZOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does ANTIFUNGAL come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is ANTIFUNGAL prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing MICONAZOLE?
Yes. 5 FDA drug label records list MICONAZOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has ANTIFUNGAL been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.