Prescription medicine
Econazole Brand names: Ecoza; first approved as Spectazole
Econazole (Spectazole) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.351 per gram (Econazole nitrate 1% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the econazole FDA label on DailyMed (effective June 22, 2026, Encube Ethicals, Inc.); the NDA 18751 record on Drugs@FDA; every econazole label on DailyMed.
Highlights of the record
FDA label of June 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEconazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
Forms and strengths
- 10 mg/g
Cream; aerosol (foam).
On the market
- Earliest approval on file
- December 23, 1982 Spectazole, Alvogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first November 26, 2002; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 6 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 8, 2031 Ecoza aerosol; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.351 per gram Econazole nitrate 1% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2022 0 Class I among all firms' recalls; latest March 24, 2022
- FAERS reports
- 920 through July 30, 2026
What is econazole used for?
From the label: indications and usageEconazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
Conditions named in the indications of econazole's FDA labels, with every medicine labeled for each:
From other econazole labelsFungal infections: INDICATIONS AND USAGE Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans …
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (Econazole Nitrate), Encube Ethicals, Inc., effective June 22, 2026 (SPL set 64d82b8b-d749-4bfe-ba3e-25836d54e115), via openFDA; the full label on DailyMed
What does the patient leaflet for econazole 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 Ecoza topical foam?Ecoza topical foam is flammable. Avoid heat, flame and smoking while applying and right after you apply Ecoza topical foam to your skin.
From the patient leaflet: How should I store Ecoza topical foam?Store Ecoza topical foam at room temperature, between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze Ecoza topical foam. Do not store Ecoza topical foam in direct sunlight. Ecoza topical foam is flammable. Keep the Ecoza topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty. Do not puncture or burn the Ecoza topical foam canister. Keep Ecoza topical foam and all medicines out of the reach of children.
Source: FDA drug label (Ecoza), Resilia Pharmaceuticals, Inc., effective December 4, 2023 (SPL set 0bb5fa27-32ed-ed13-e063-6394a90a1577), via openFDA; the full label on DailyMed
Is there a generic for econazole (Spectazole)?
The FDA approved the first generic econazole on November 26, 2002. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists econazole from 6 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Spectazole cream; a patent listed only for Ecoza aerosol runs to August 8, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1982 earliest approval on file
- 2002 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for econazole (Spectazole)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.351 per gram (Econazole nitrate 1% cream), up 7% from $0.328 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Econazole nitrate 1% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Econazole nitrate 1% cream | Generic | $0.351 per gram | n/a | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has econazole been recalled?
The FDA's Enforcement Report lists 2 recalls naming econazole since 2022: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 24, 2022 | Class II | Preferred Pharmaceuticals, Inc. | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study … |
| March 15, 2022 | Class II | Teligent Pharma, Inc. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the econazole label say about other medicines?
The econazole label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Drug Interactions Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. |
Source: FDA drug label (Econazole Nitrate), Encube Ethicals, Inc., effective June 22, 2026 (SPL set 64d82b8b-d749-4bfe-ba3e-25836d54e115), via openFDA; the full label on DailyMed
What do FAERS reports show for econazole?
The FDA Adverse Event Reporting System holds 920 reports that list econazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 331 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 econazole?
18 other medicines are given the same way (topical) and in the same FDA class as econazole 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 |
| 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 |
| Miconazole and petrolatum and zinc oxide | Fungal infections | none listed | $9.12 per gram 0.25-15% | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does econazole compare with medicines for the same use?
4 side-by-side pages set econazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to econazole
- 18 medicines for the same use
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Econazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other