Prescription and over-the-counter medicine
Miconazole Brand names: Monistat, Oravig; first approved as Monistat-Derm
Miconazole (Monistat) is a prescription and over-the-counter medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.120 per gram (Miconazole 2% topical cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the miconazole FDA label on DailyMed (effective July 21, 2026, WALGREEN COMPANY); the NDA 17494 record on Drugs@FDA; every miconazole label on DailyMed.
Highlights of the record
FDA label of July 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetreats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
- 2 g/100g
- 20 mg/g
- 20 mg/100g
- 40 mg/g
- 100 mg/g
Kit; cream; suppository; tablet.
On the market
- Earliest approval on file
- January 8, 1974 Monistat-Derm, Insight Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first October 30, 1992; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 46 of which 43 under generic applications, 4 under brand applications, repackagers included; 102 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.120 per gram Miconazole 2% topical cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest April 10, 2015; 2 more by firms not listed as its makers
- FAERS reports
- 8,710 through July 30, 2026
What is miconazole used for?
From the label: indications and usagetreats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Conditions named in the indications of miconazole's FDA labels, with every medicine labeled for each:
From other miconazole labelsFungal infections: Uses proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm for effective relief of itching, scaling, cracking, burning, and discomfort
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (Miconazole 3 Walgreen Company), NDA020670 (Medtech Products), as published by WALGREEN COMPANY, effective July 21, 2026 (SPL set 32b373be-9c8e-49b0-a796-8d87f6a20cef), via openFDA; the full label on DailyMed
Is there a generic for miconazole (Monistat)?
The FDA approved the first generic miconazole on October 30, 1992. 18 generic applications are approved; 11 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 miconazole from 43 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1974 earliest approval on file
- 1992 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 miconazole (Monistat)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.120 per gram (Miconazole 2% topical cream), about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Miconazole 2% topical cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Antifungal 2% powder | Generic | $0.0579 per gram | n/a | +2% |
| Antifungal 2% topical cream | Generic | $0.0788 per gram | n/a | n/a |
| Athlete's foot 2% powder spray | Generic | $0.0361 per gram | n/a | -0.1% |
| Ft antifungal 2% topical cream | Generic | $0.121 per gram | n/a | -8% |
| Ft miconazole 1 combo pack | Generic | $11.55 per unit | n/a | n/a |
| Ft miconazole 3 combo pack | Generic | $3.92 per gram | n/a | -8% |
| Ft miconazole 7 cream | Generic | $0.119 per gram | n/a | -7% |
| Gnp miconazole 1 combo pack | Generic | $11.55 per unit | n/a | -2% |
| Gnp miconazorb af 2% powder | Generic | $0.0579 per gram | n/a | +2% |
| Gs miconazole 3 combo pack | Generic | $7.43 per unit | n/a | -9% |
| Gs miconazole 7 cream | Generic | $0.119 per gram | n/a | -7% |
| Miconazole 2% topical cream | Generic | $0.120 per gram | n/a | +0.5% |
| Miconazole 2% vaginal cream | Generic | $0.119 per gram | n/a | -7% |
| Miconazole 3 200 mg vag supp | Generic | $13.89 per unit | n/a | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has miconazole been recalled?
The FDA's Enforcement Report lists 3 recalls naming miconazole since 2015: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of miconazole and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 10, 2024 | Class II | MEDLINE INDUSTRIES, LP - Northfield not a listed maker | Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the … |
| October 4, 2023 | Class II | MEDLINE INDUSTRIES, LP - Northfield not a listed maker | CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low … |
| April 10, 2015 | Class III | Medtech Products, Inc. | Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the miconazole label say about other medicines?
The miconazole label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name miconazole. 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 |
|---|---|---|
| Phenytoin | drug interactions (prescription label) | … the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out. |
| Warfarin | drug interactions (prescription label) | DRUG INTERACTIONS Warfarin: Miconazole may enhance anticoagulant effect. |
Other labels that name miconazole
Source: FDA drug label (Miconazole 3 Walgreen Company), NDA020670 (Medtech Products), as published by WALGREEN COMPANY, effective July 21, 2026 (SPL set 32b373be-9c8e-49b0-a796-8d87f6a20cef), via openFDA; the full label on DailyMed
What do FAERS reports show for miconazole?
The FDA Adverse Event Reporting System holds 8,710 reports that list miconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 434 are coded as a death and 1,644 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
How does miconazole compare with medicines for the same use?
2 side-by-side pages set miconazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Miconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other