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Nystatin Oral Suspension

Generic: NYSTATIN

Verified·Apr 23, 2026
NDC
0116-4026
RxCUI
884308
Route
TOPICAL
ICD-10 indication
B37.0

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About Nystatin Oral Suspension

Nystatin oral suspension is an antifungal medication prescribed primarily to treat fungal infections of the mouth, commonly known as oral thrush or candidiasis. It belongs to a class of drugs called polyenes and works by binding to sterols in the cell membranes of fungi, causing the cells to leak and die. This medication is specifically effective against Candida species and is often used for infants, children, and adults who have developed white patches or sores in the mouth due to yeast overgrowth. The medication is typically taken as a liquid that patients swish around their mouth to ensure it covers all affected areas before swallowing or spitting it out as directed by a healthcare provider. It is important to continue using the suspension for the full duration of the prescription to ensure the infection is completely eradicated. Common side effects are generally mild but may include nausea or stomach upset.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Nystatin Oral Suspension. Official source: DailyMed (NLM) · Label effective Feb 6, 2026

Indications and usage
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Dosage and administration
DOSAGE AND ADMINISTRATION INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4-6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .
Contraindications
CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
Adverse reactions
ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ). Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use in pregnancy
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How Nystatin Oral Suspension appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

71%

3,913 of 5,509 plans

Most common tier

Tier 2

On 66% of covering formularies

Prior authorization required

0%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)104
32%
Tier 2 (generic)218
66%
Tier 3 (preferred brand)3
1%
Tier 4 (non-preferred brand)4
1%

Step therapy: 0% of formularies

Quantity limits: 60% of formularies

Coverage breadth: 329 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.