Uses
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
Source: US FDA prescribing information
- Presentations
- 12
- Brands
- 4
- Manufacturers
- 4
- Available from stock
- 0
Nystatin is a polyene antifungal indicated for the treatment of infections of the oral cavity caused by Candida albicans. It is available as cream, oral suspension and topical powder. MedsAcross supplies Nystatin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Polyene Antifungal
- ATC classification
- A07AA02 Nystatin · Diarrhoea treatments and intestinal anti-inflammatories, subgroup A07A, subgroup A07AAD01AA01 Nystatin · Antifungals for the skin, subgroup D01A, subgroup D01AAG01AA01 Nystatin · Gynaecological anti-infectives, subgroup G01A, subgroup G01AA
- US FDA first approval
- 14 April 1971
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Topical, Oral
- Dosage forms
- Cream, Oral suspension, Topical powder, Ointment, Tablet
- Identifiers
- UNII BDF1O1C72ERxCUI 7597CAS 1400-61-9DrugBank DB00646Q251005
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth). Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective. Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.
Source: US FDA prescribing information
Contraindications
Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
Source: US FDA prescribing information
Warnings and precautions
General Discontinue treatment with nystatin if sensitization or irritation is reported during use. Nystatin is not effective in the treatment of systemic mycoses since it is not significantly absorbed from the gastrointestinal tract. Information for the Patient Patient should be advised to retain nystatin in the mouth as long as possible and to continue its use for at least 2 days after symptoms have subsided. There should be no interruption or discontinuation of the medication until the prescribed course of treatment is completed, even though symptomatic relief may occur within a few days. If symptoms of local irritation develop, the physician should be notified immediately.
Source: US FDA prescribing information
Side effects
Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.
Source: US FDA prescribing information
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). DO NOT FREEZE Manufactured for: Chartwell RX, LLC.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
12 presentations of Nystatin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Nystatin 100000 units/g creamTopicalGeneric name | — | US FDA | Available on request |
| Nystatin 100000 units/mL oral suspensionOralGeneric name | — | US FDA | Available on request |
| Nystatin 100000 units/g ointmentTopicalGeneric name | — | US FDA | Available on request |
| Nystatin 100000 units/g topical powderTopicalGeneric name | — | US FDA | Available on request |
| Nystatin 500000 units tabletOralGeneric name | — | US FDA | Available on request |
| Nystop 100000 units/g topical powderTopical | Padagis | US FDA | Available on request |
| Klayesta 100000 units/g topical powderTopical | Epic Pharma | US FDA | Available on request |
| Nyamyc 100000 units/g topical powderTopical | Upsher-Smith Laboratories | US FDA | Available on request |
| Nystatin 100000/g creamTopicalGeneric name | — | US FDA | Available on request |
| Nystatin 100000/g ointmentTopicalGeneric name | — | US FDA | Available on request |
| Mycostatin 100000 units/g creamTopical | Direct_Rx | US FDA | Available on request |
| Nystatin 100000 units/g creamOral, topicalGeneric name | — | US FDA | Available on request |
Brands by market
4 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 14 April 1971 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Nystatin in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Nystatin available for export from India?
Yes, on request. MedsAcross lists 12 presentations of Nystatin and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Nystatin have?
The catalogue lists 4 brand names for Nystatin, including Klayesta, Mycostatin, Nyamyc, Nystop.
Is Nystatin approved by the US FDA?
Yes. The US FDA first approved Nystatin on 14 April 1971, according to Drugs@FDA.
Does Nystatin need cold chain shipping?
No listed presentation of Nystatin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Nystatin in?
Nystatin is classified under ATC code A07AA02 (Nystatin).
References
- Nystatin prescribing information (Chartwell RX). U.S. National Library of Medicine, DailyMed. Retrieved 5 March 2026
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