Prescription medicine
Efinaconazole Brand names: Jublia
Efinaconazole (Jublia) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the efinaconazole FDA label on DailyMed (effective July 1, 2025, Bausch Health US LLC); the NDA 203567 record on Drugs@FDA; every efinaconazole label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageJUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Forms and strengths
- 100 mg/ml
Solution.
On the market
- Earliest approval on file
- June 6, 2014 Jublia, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first December 16, 2020; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 25, 2035 Jublia solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,933 through July 30, 2026
What is efinaconazole used for?
From the label: indications and usageJUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Conditions named in the indications of efinaconazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (JUBLIA), Bausch Health US LLC, effective July 1, 2025 (SPL set 922d4d25-c530-11e1-9b21-0800200c9a66), via openFDA; the full label on DailyMed
What does the patient leaflet for efinaconazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using JUBLIA?JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
From the patient leaflet: How should I store JUBLIA?Store JUBLIA at room temperature, between 68°F to 77°F (20°C to 25°C). Do not freeze JUBLIA. • Keep the bottle tightly closed and store in upright position. • JUBLIA is flammable. Keep away from heat and flame. Keep JUBLIA and all medicines out of reach of children.
Source: FDA drug label (JUBLIA), Bausch Health US LLC, effective July 1, 2025 (SPL set 922d4d25-c530-11e1-9b21-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for efinaconazole (Jublia)?
The FDA approved the first generic efinaconazole on December 16, 2020. 7 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 18 patents for Jublia solution, the last expiring on April 25, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2020 first generic approved
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for efinaconazole?
The FDA Adverse Event Reporting System holds 1,933 reports that list efinaconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 102 are coded as a death and 395 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as efinaconazole?
18 other medicines are given the same way (topical) and in the same FDA class as efinaconazole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clotrimazole | Fungal infections | 13 labelers | $0.133 per gram 1% topical cream | No current entry |
| Miconazole | Fungal infections | none listed | $0.120 per gram 2% topical cream | No current entry |
| Ketoconazole | Fungal infections | 25 labelers | $0.249 per gram 2% cream | No current entry |
| Betamethasone and clotrimazole | Fungal infections | 16 labelers | $0.190 per gram Clotrimazole-betamethasone cream | No current entry |
| Econazole | Fungal infections | 6 labelers | $0.351 per gram 1% cream | No current entry |
| Sulconazole | Fungal infections | none listed | n/a | A presentation being discontinued |
| Oxiconazole | Fungal infections | 1 labeler | $3.92 per gram 1% cream | No current entry |
| Luliconazole | Fungal infections | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as efinaconazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to efinaconazole
- 18 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Efinaconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other