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Nystop

nystatin · Nystop is a polyene antifungal (prescription) containing nystatin, made by Padagis US LLC.

Type
Prescription
Drug class
Polyene Antifungal
Route
Topical
Manufacturers
1
+ 6 repackager labels

Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Uses

Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage and administration

Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older): Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

Contraindications

Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Precautions

General Nystatin Topical Powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens. INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: 1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. 2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. 3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly. Laboratory Tests If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. Pregnancy: Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman. Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).

Side effects (adverse reactions)

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General .)

Pregnancy

Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Use in children

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).

Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C 47 H 75 NO 17. The molecular weight of Nystatin is 926.1. Structural formula: Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc. Structural Formula

How supplied

Nystop ® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles. (NDC 0574-2008-15) (NDC 0574-2008-30) (NDC 0574-2008-02) STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4

Storage and handling

STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4

Forms and strengths

From the FDA NDC Directory · 7 product codes

Dosage formStrengthRouteNDCs
Powder100000 [USP'U]/gtopical7

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/28/2026

All prices

Pharmacies paid about $0.253 to $0.402 per gram across 3 package codes.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 27,182 reports that list nystatin, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Nausea2,060
  • Fatigue1,850
  • Diarrhea1,839
  • Pneumonia1,683
  • Dyspnea1,535
  • Off label use1,477
  • Vomiting1,405
  • Drug ineffective1,290
  • Pain1,279
  • Death1,220

To report a side effect, use FDA MedWatch.

Manufacturers and labels

7 FDA labels · 6 from repackagers

  • Padagis US LLCShown hereANDA064118 · Label 10/31/2024 · NDC 0574-2008Full label
Repackager labels (6)
  • Bryant Ranch Prepack07/14/2026
  • Bryant Ranch Prepack10/21/2025
  • Bryant Ranch Prepack10/21/2025
  • Bryant Ranch Prepack08/26/2025
  • Bryant Ranch Prepack03/22/2024
  • Bryant Ranch Prepack01/11/2024

Nystop: common questions

What is Nystop used for?
Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
What are the side effects of Nystop?
The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS... See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
Is Nystop a prescription drug?
Yes. Nystop is a prescription (Rx) drug.
Are there other products with the same active ingredient as Nystop?
Yes. Other FDA-listed products with the same active ingredients include Nystatin, Nystatin, Nystatin, Nystatin Topical Powder.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/14/2026 · Label text is shown as published by the manufacturer. Not medical advice

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