FDA label
What is nystatin used for?
The FDA-approved uses of nystatin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.”
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Nystatin, cream
Indications and Usage, quoted from the label by Torrent Pharmaceuticals Limited (ANDA212557). Cross-references to other label sections are left out.
Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
Source: DailyMed label, set id 559b5bd4-3564-4437-8d0a-fa3a972f8b83, version 9, effective May 1, 2026. NDC 13668-595, one of 33 listings for this product.
Nystatin, suspension
Indications and Usage, quoted from the label by Kesin Pharma Corporation (ANDA062832). Cross-references to other label sections are left out.
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Source: DailyMed label, set id 50737729-a4a4-e747-e063-6394a90adcc5, version 1, effective June 30, 2026. NDC 81033-015, one of 20 listings for this product.
Nystatin, powder
Indications and Usage, quoted from the label by Upsher-Smith Laboratories, LLC (ANDA065183). Cross-references to other label sections are left out.
Nyamyc®(Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candidaspecies.
Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.
Source: DailyMed label, set id 01b44f91-9b68-464a-9693-b5d3e793bf3c, version 12, effective July 9, 2025. NDC 0832-0465, one of 16 listings for this product.
Questions
What is nystatin used for?
The FDA label says: “Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.”
What drug class is nystatin?
FDA lists nystatin in the Polyene Antifungal established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Nystatin
- Is Nystatin a controlled substance?Federal schedule
- Generic for NilstatFDA Orange Book
- What is Nystop used for?FDA label uses
- Is Nystop a controlled substance?Federal schedule
- What is Nyamyc used for?FDA label uses
- Is Nyamyc a controlled substance?Federal schedule
- What is Klayesta used for?FDA label uses
- Is Klayesta a controlled substance?Federal schedule
- Polyene Antifungals listFDA drug class
- NDC 0093-0983Nystatin NDC record
- NDC 0116-4026Nystatin NDC record
- NDC 0121-0810Nystatin NDC record