Over-the-counter medicine
Tioconazole First approved as Tz-3
Tioconazole (Tz-3) is an over-the-counter medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $2.41 per gram (Tioconazole-1 6.5% ointment) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the tioconazole FDA label on DailyMed (effective December 19, 2023, L. Perrigo Company); the NDA 18682 record on Drugs@FDA; every tioconazole label on DailyMed.
Highlights of the record
FDA label of December 19, 2023; 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
Forms and strengths
- 6.5 g/100g
Ointment.
On the market
- Earliest approval on file
- February 18, 1983 Tz-3, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first November 21, 2001; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 17 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.41 per gram Tioconazole-1 6.5% ointment
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,541 through July 30, 2026
What is tioconazole used for?
From the label: indications and usagetreats vaginal yeast infections
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (good sense tioconazole 1), L. Perrigo Company, effective December 19, 2023 (SPL set d39ac447-6e1d-4b77-90c1-a9a653661f42), via openFDA; the full label on DailyMed
Is there a generic for tioconazole (Tz-3)?
The FDA approved the first generic tioconazole on November 21, 2001. 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 tioconazole from 17 labelers 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.
- 1983 earliest approval on file
- 2001 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tioconazole (Tz-3)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.41 per gram (Tioconazole-1 6.5% ointment), up 3% from $2.34 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.
- Ft tioconazole-1 6.5% ointment (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft tioconazole-1 6.5% ointment | Generic | $2.41 per gram | n/a | +3% |
| Tioconazole 1 6.5% ointment | Generic | $2.41 per gram | n/a | +3% |
| Tioconazole-1 6.5% ointment | Generic | $2.41 per gram | 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
What do FAERS reports show for tioconazole?
The FDA Adverse Event Reporting System holds 1,541 reports that list tioconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 42 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 next?
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Tioconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other