Quick answers
- What is Sulconazole nitrate used for?
- The FDA-approved label (Exelderm, Journey Medical Corporation, June 8, 2026) says: “EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sulconazole nitrate have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sulconazole nitrate?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated May 8, 2026). Ask your pharmacist about alternatives.
- Has Sulconazole nitrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sulconazole nitrate?
- 3 companies list prescription products of Sulconazole nitrate in the FDA NDC Directory, including Journey Medical Corporation, JG Pharma Inc. and JG Pharma.
What Sulconazole nitrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). …
— FDA label: Exelderm, Journey Medical Corporation, effective June 8, 2026. Read the full label on DailyMed →
The FDA has 4 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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Cream |
|---|---|
| Route | Topical |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Exelderm |
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.
- Journey Medical Corporation2 products
- JG Pharma Inc.1 product
- JG Pharma1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018737 EXELDERM | Journey | February 28, 1989 | 4, latest November 26, 2013 2013: Manufacturing (CMC) · 2003: Labeling · 2001: Manufacturing (CMC) |
| NDA018738 EXELDERM | Journey | August 30, 1985 | 10, latest May 19, 2014 2014: Manufacturing (CMC) · 2009: Manufacturing (CMC) · 2003: Labeling |
Shortage status
To be discontinued · updated May 8, 2026 · first posted May 8, 2026
| Product | Sulconazole Nitrate, Solution, 30 mL (NDC 72143-321-30) |
|---|---|
| Company | Journey Medical Corporation |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 106366, 208117, 208118, 313125 |
|---|---|
| SPL set ID of the quoted label | 5b73e83e-8d3c-4d96-b4f6-9f854430add8 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA018737, NDA018738 |
| Active ingredients (FDA) | SULCONAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Exelderm, Journey Medical Corporation, effective June 8, 2026; 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 →