Quick answers
- What is Butoconazole nitrate used for?
- The FDA-approved label (Gynazole 1, Padagis Israel Pharmaceuticals Ltd, June 1, 2023) says: “GYNAZOLE • 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Butoconazole nitrate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Butoconazole nitrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Butoconazole nitrate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 28, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Butoconazole nitrate?
- 1 company lists prescription products of Butoconazole nitrate in the FDA NDC Directory, including Padagis Israel Pharmaceuticals Ltd.
What Butoconazole nitrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GYNAZOLE • 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 …
— FDA label: Gynazole 1, Padagis Israel Pharmaceuticals Ltd, effective June 1, 2023. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Cream |
|---|---|
| Route | Vaginal |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Gynazole 1 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| butoconazole nitrate 100 mg/5 g cream | Brand: Gynazole 1 | $23.38 per gram |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Padagis Israel Pharmaceuticals Ltd1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA200923Padagis Israel · May 18, 2012
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 28, 2023 · Class II · Ongoing · D-0081-2024
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, — Padagis US LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 890785, 890786 |
|---|---|
| SPL set ID of the quoted label | 125d8ede-db38-4eb9-a6be-19208687f36a |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | BUTOCONAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gynazole 1, Padagis Israel Pharmaceuticals Ltd, effective June 1, 2023; 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 →