Prescription medicine
Terconazole First approved as Terazol
Terconazole (Terazol) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.552 per gram (Terconazole 0.4% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the terconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the NDA 19579 record on Drugs@FDA; every terconazole label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTerconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis).
Forms and strengths
- 80 mg
- 4 mg/g
- 8 mg/g
Cream; suppository.
On the market
- Earliest approval on file
- December 31, 1987 Terazol 7, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first April 6, 2004; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.552 per gram Terconazole 0.4% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest January 26, 2022
- FAERS reports
- 822 through July 30, 2026
What is terconazole used for?
From the label: indications and usageTerconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Conditions named in the indications of terconazole's FDA labels, with every medicine labeled for each:
From other terconazole labelsFungal infections: INDICATIONS AND USAGE Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis).
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (Terconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set 10e84353-93d2-461d-8b79-e9294df047ae), via openFDA; the full label on DailyMed
Is there a generic for terconazole (Terazol)?
The FDA approved the first generic terconazole on April 6, 2004. 6 generic applications are approved; 5 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 terconazole from 6 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2004 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 terconazole (Terazol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.552 per gram (Terconazole 0.4% cream), down 6% from $0.591 on October 8, 2025. 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.
- Terconazole 0.4% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Terconazole 0.4% cream | Generic | $0.552 per gram | n/a | -6% |
| Terconazole 0.8% cream | Generic | $0.987 per gram | n/a | -6% |
| Terconazole 80 mg suppository | Generic | $18.62 per suppository | 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 terconazole been recalled?
The FDA's Enforcement Report lists 1 recall naming terconazole since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for terconazole?
The FDA Adverse Event Reporting System holds 822 reports that list terconazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 169 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 terconazole?
1 other medicine is given the same way (vaginal) and in the same FDA class as terconazole 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 |
|---|---|---|---|---|
| Butoconazole | Fungal infections | 1 labeler | $23.30 per gram 1 2% cream | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does terconazole compare with medicines for the same use?
2 side-by-side pages set terconazole 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
- Terconazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other