Quick answers
- What is Tavaborole used for?
- The FDA-approved label (Tavaborole, Encube Ethicals, Inc., September 15, 2025) says: “Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tavaborole have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tavaborole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tavaborole been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 6, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tavaborole?
- 7 companies list prescription products of Tavaborole in the FDA NDC Directory, including Viona Pharmaceuticals Inc, Alembic Pharmaceuticals Inc. and Encube Ethicals, Inc..
What Tavaborole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
— FDA label: Tavaborole, Encube Ethicals, Inc., effective September 15, 2025. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Topical |
| Prescription products | 7 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tavaborole 43.5 mg/mL solution | Generic | $3.38 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Viona Pharmaceuticals Inc1 product
- Alembic Pharmaceuticals Inc.1 product
- Encube Ethicals, Inc.1 product
- Chartwell RX, LLC1 product
- Mayne Pharma Commercial LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Zydus Lifesciences Limited1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA211297Encube · October 13, 2020
- ANDA212188Alembic · October 21, 2020
- ANDA211963Chartwell Rx · February 3, 2021
- ANDA212294Zydus Lifesciences · April 10, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 6, 2025 · Class II · Ongoing · D-0016-2026
Discoloration
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. — VIONA PHARMACEUTICALS INC
-
August 12, 2025 · Class II · Ongoing · D-0595-2025
Discoloration
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. — VIONA PHARMACEUTICALS INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1543177 |
|---|---|
| SPL set ID of the quoted label | 050f5d10-5591-426e-9020-6516b3363304 |
| FDA labels (SPL) | 7 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | TAVABOROLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tavaborole, Encube Ethicals, Inc., effective September 15, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →