Prescription medicine
Sertaconazole Brand names: Ertaczo
Sertaconazole (Ertaczo) is a prescription medicine with an FDA approval on record since 2003. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sertaconazole FDA label on DailyMed (effective December 9, 2024, Lacer Pharma, LLC); the NDA 21385 record on Drugs@FDA; every sertaconazole label on DailyMed.
Highlights of the record
FDA label of December 9, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Forms and strengths
- 20 mg/g
Cream.
On the market
- Earliest approval on file
- December 10, 2003 Ertaczo, Lacer Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
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
- 156 through July 30, 2026
What is sertaconazole used for?
From the label: indications and usageERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Conditions named in the indications of sertaconazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (Ertaczo), Lacer Pharma, LLC, effective December 9, 2024 (SPL set 27d51f01-3282-34ea-e063-6394a90a91ed), via openFDA; the full label on DailyMed
Is there a generic for sertaconazole (Ertaczo)?
No generic sertaconazole is approved (Drugs@FDA, October 8, 2026).
- 2003 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for sertaconazole?
The FDA Adverse Event Reporting System holds 156 reports that list sertaconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 59 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.
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 sertaconazole?
18 other medicines are given the same way (topical) and in the same FDA class as sertaconazole 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 sertaconazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sertaconazole
- 18 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Sertaconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other