Prescription medicine
Butoconazole Brand names: Gynazole; first approved as Femstat
Butoconazole (Gynazole) is a prescription medicine with an FDA approval on record since 1995. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $23.30 per gram (Gynazole 1 2% cream).
- Generic approved
Check it at the source: the butoconazole FDA label on DailyMed (effective June 1, 2023, Padagis Israel Pharmaceuticals Ltd); the NDA 20421 record on Drugs@FDA; every butoconazole label on DailyMed.
Highlights of the record
FDA label of June 1, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGYNAZOLE
1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida ).
Forms and strengths
- 100 mg/5g
Cream.
On the market
- Earliest approval on file
- December 21, 1995 Femstat 3, Bayer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first May 18, 2012; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $23.30 per gram Gynazole 1 2% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest September 28, 2023
- FAERS reports
- 5 through July 30, 2026
What is butoconazole used for?
From the label: indications and usageGYNAZOLE
1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida ). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES ). Note: GYNAZOLE
1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see PRECAUTIONS - Pregnancy ).
Conditions named in the indications of butoconazole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (gynazole 1), Padagis Israel Pharmaceuticals Ltd, effective June 1, 2023 (SPL set 125d8ede-db38-4eb9-a6be-19208687f36a), via openFDA; the full label on DailyMed
Is there a generic for butoconazole (Gynazole)?
The FDA approved the first generic butoconazole on May 18, 2012. 1 generic application is approved; 1 of it carries 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 butoconazole from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
- 1995 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for butoconazole (Gynazole)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $23.30 per gram (Gynazole 1 2% cream), down 1% from $23.55 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.
- Gynazole 1 2% cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gynazole 1 2% cream | Brand | $23.30 per gram | n/a | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has butoconazole been recalled?
The FDA's Enforcement Report lists 1 recall naming butoconazole since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 28, 2023 | Class II | Padagis US LLC | Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for butoconazole?
The FDA Adverse Event Reporting System holds 5 reports that list butoconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 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 butoconazole?
1 other medicine is given the same way (vaginal) and in the same FDA class as butoconazole 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. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (vaginal) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Terconazole | Fungal infections | 6 labelers | $0.552 per gram 0.4% cream | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Butoconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other