{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "NYSTATIN NYSTATIN EDETATE DISODIUM SODIUM BENZOATE HEXASODIUM HEXAMETAPHOSPHATE SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLPARABEN SUCROSE PEPPERMINT OIL NYSTATIN NYSTATIN MINT" ], "description": [ "DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: cherry flavor, dibasic sodium phosphate heptahydrate, disodium edetate, glycerin, methylparaben, monobasic sodium phosphate monohydrate, peppermint oil, propylparaben, sodium benzoate, sodium hexametaphosphate, and sucrose. image description" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur. Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels o f nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses." ], "pharmacokinetics": [ "Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur." ], "microbiology": [ "Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels o f nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses." ], "indications_and_usage": [ "INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity." ], "contraindications": [ "CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components." ], "precautions": [ "PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy Teratogenic Effects Category C 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. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION." ], "general_precautions": [ "General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females." ], "pregnancy": [ "Pregnancy Teratogenic Effects Category C 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. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION." ], "teratogenic_effects": [ "Teratogenic Effects Category C 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." ], "nursing_mothers": [ "Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman." ], "pediatric_use": [ "Pediatric Use See DOSAGE AND ADMINISTRATION." ], "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 Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch." ], "overdosage": [ "OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics )." ], "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: L imited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4 to 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 ." ], "how_supplied": [ "HOW SUPPLIED Nystatin Oral Suspension, USP 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, yellow, ready-to-use suspension, supplied in the following oral dosage forms: NDC 81033-015-60: 60 mL bottle with a 1 mL calibrated dropper NDC 81033-015-16: 16 oz (473 mL) bottle Rx Only" ], "storage_and_handling": [ "SHAKE WELL BEFORE USE SHAKE WELL BEFORE USE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. AVOID FREEZING Pharmacists: Dispense in a tight, light-resistant container as defined in the USP. Distributed by: Kesin Pharma Oldsmar, FL 34677 Revised: 12/2025 PI-015B-V01 Kesin Pharma Logo" ], "package_label_principal_display_panel": [ "Nystatin 16 oz (473 mL) Rx Only NDC 81033- 015- 16 Nystatin Oral Suspension, USP SHAKE WELL BEFORE USING Nystatin 16 oz (473 mL) Bottle Label", "Nystatin 60 mL Bottle and Carton Labels Rx Only NDC 81033- 015 -60 Nystatin Oral Suspension, USP SHAKE WELL BEFORE USING Rx Only NDC 81033- 015 -60 Nystatin Oral Suspension, USP SHAKE WELL BEFORE USING (Includes safe cap dropper) Nystatin 60 mL Bottle Label Nystatin 60 mL Bottle Carton Label" ], "set_id": "50737729-a4a4-e747-e063-6394a90adcc5", "id": "50738a43-7297-270c-e063-6294a90af2cc", "effective_time": "20260630", "version": "1", "openfda": { "application_number": [ "ANDA062832" ], "brand_name": [ "NYSTATIN" ], "generic_name": [ "NYSTATIN" ], "manufacturer_name": [ "Kesin Pharma Corporation" ], "product_ndc": [ "81033-015" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NYSTATIN" ], "rxcui": [ "312055" ], "spl_id": [ "50738a43-7297-270c-e063-6294a90af2cc" ], "spl_set_id": [ "50737729-a4a4-e747-e063-6394a90adcc5" ], "package_ndc": [ "81033-015-16", "81033-015-60" ], "original_packager_product_ndc": [ "85742-013" ], "nui": [ "N0000175498", "M0017172" ], "pharm_class_epc": [ "Polyene Antifungal [EPC]" ], "pharm_class_cs": [ "Polyenes [CS]" ], "unii": [ "BDF1O1C72E" ] } } ] }