Nystatin
Cream · Topical, Oral
Uses
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans .
Dosage and administration
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.
Contraindications
Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
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. Laboratory Tests If there is a lack of therapeutic response, appropriate microbiological studies (e.g., KOH smears and/or cultures) should be repeated to confirm the diagnosis of candidiasis and rule out other pathogens before instituting another course of therapy. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. In mice exposed to nystatin 50 mg/kg by injection, an increased incidence of chromosomal aberrations, consisting primarily of chromatid breaks, was observed in bone marrow cells. However, there have been no studies to determine the mutagenicity of orally-administered nystatin or its effects on fertility in males or females. Pregnancy Teratogenic effects Teratogenicity studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed. Nonteratogenic effects In one rat reproductive study, nystatin was administered orally to pregnant rats in single doses of 100, 500, or 3000 mg/kg on the ninth day of gestation, or as multiple doses of 500 mg/kg/day on gestation days 1-20, 1-4, 7-10, 11-14, or 15-18. It was found that nystatin had a slight abortive effect when used during the whole period of pregnancy. No abnormalities were seen in surviving fetuses. Although no adverse effects or complications have been attributed to the use of intra-vaginal nystatin in neonates born to women treated during pregnancy, no similar studies evaluating complications of oral nystatin have been conducted. 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 section for pediatric dosing recommendations.
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.
Overdosage
Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.
Description
Nystatin, USP is obtained from Streptomyces noursei . It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Its structural formula is: C 47 H 75 NO 17 M.W .926 .13 Nystatin Oral Suspension, USP, is a cherry-flavored, ready-to-use suspension containing 100,000 units of Nystatin, USP per mL. Nystatin, USP contains the following inactive ingredients: artificial (wild) cherry flavor, D&C Yellow 10, edetate calcium disodium, hydrochloric acid, methylparaben, polysorbate 80, propylparaben, purified bentonite, purified water, sodium hydroxide and sucrose. image description
How supplied
Nystatin Oral Suspension, USP is a bright yellow color suspension with cherry flavor containing 100,000 units of nystatin per mL, supplied as follows: NDC 62135-813-46 – bottle of 60 mL with dropper NDC 62135-813-47 – bottle of 473 mL Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). DO NOT FREEZE Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71884 Rev. 03/2026
Label text from the FDA structured product label by Chartwell RX, LLC (revised Mar 5, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Nystatin in 78 products
Nystatin NDC products (78)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7303 | Nystatin 100000 U/g Cream | A-S Medication Solutions | ANDA |
| 50090-2763 | Nystatin 100000 [USP'U]/g Cream | A-S Medication Solutions | ANDA |
| 50090-1740 | Nystatin 100000 [USP'U]/mL Suspension | A-S Medication Solutions | ANDA |
| 50090-2854 | Nystatin 100000 [USP'U]/g Cream | A-S Medication Solutions | ANDA |
| 50090-3772 | Nystatin 100000 [USP'U]/g Cream | A-S Medication Solutions | ANDA |
| 50090-3799 | Nystatin 100000 [USP'U]/g Cream | A-S Medication Solutions | ANDA |
| 50090-5315 | Nystatin 100000 [USP'U]/mL Suspension | A-S Medication Solutions | ANDA |
| 50090-5845 | Nystatin 100000 U/g Ointment | A-S Medication Solutions | ANDA |
| 0472-0166 | Nystatin 100000 [USP'U]/g Ointment | Actavis Pharma, Inc. | ANDA |
| 60687-800 | Nystatin 100000 [USP'U]/mL Suspension | American Health Packaging | ANDA |
| 17856-0508 | Nystatin 100000 [USP'U]/mL Suspension | ATLANTIC BIOLOGICALS CORP. | ANDA |
| 59651-907 | Nystatin 100000 [USP'U]/g Cream | Aurobindo Pharma Limited | ANDA |
| 42291-651 | Nystatin 500000 [USP'U]/1 Tablet, Film Coated | AvKARE | ANDA |
| 63629-8695 | Nystatin 100000 [USP'U]/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-2515 | Nystatin 100000 U/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-8694 | Nystatin 100000 [USP'U]/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-8520 | Nystatin 100000 [USP'U]/mL Suspension | Bryant Ranch Prepack | ANDA |
| 63629-8350 | Nystatin 500000 [USP'U]/1 Tablet, Coated | Bryant Ranch Prepack | ANDA |
| 63629-2516 | Nystatin 100000 U/g Ointment | Bryant Ranch Prepack | ANDA |
| 71335-2830 | Nystatin 100000 [USP'U]/g Cream | Bryant Ranch Prepack | ANDA |
| 72162-1385 | Nystatin 100000 [USP'U]/g Cream | Bryant Ranch Prepack | ANDA |
| 72162-2007 | Nystatin 100000 U/g Ointment | Bryant Ranch Prepack | ANDA |
| 72162-2645 | Nystatin 100000 U/mL Suspension | Bryant Ranch Prepack | ANDA |
| 72162-2333 | Nystatin 100000 [USP'U]/g Ointment | Bryant Ranch Prepack | ANDA |
| 72162-2496 | Nystatin 100000 [USP'U]/g Cream | Bryant Ranch Prepack | ANDA |
| 72162-2576 | Nystatin 100000 U/g Cream | Bryant Ranch Prepack | ANDA |
| 55154-5788 | Nystatin 100000 [USP'U]/mL Suspension | Cardinal Health 107, LLC | ANDA |
| 55154-4314 | Nystatin 100000 [USP'U]/mL Suspension | Cardinal Health 107, LLC | ANDA |
| 62135-741 | Nystatin 500000 [USP'U]/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 0713-0686 | Nystatin 100000 [USP'U]/g Ointment | Cosette Pharmaceuticals, Inc. | ANDA |
| 0713-0678 | Nystatin 100000 [USP'U]/g Cream | Cosette Pharmaceuticals, Inc. | ANDA |
| 72189-278 | Nystatin 100000 [USP'U]/g Cream | DIRECT RX | ANDA |
| 75907-060 | Nystatin 100000 [USP'U]/g Powder | Dr. Reddy's Labratories Inc. | ANDA |
| 64950-372 | Nystatin 100000 [USP'U]/mL Suspension | Genus Lifesciences Inc. | ANDA |
| 23155-051 | Nystatin 500000 [USP'U]/1 Tablet, Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 85742-013 | Nystatin 100000 U/mL Suspension | Kanchan Healthcare Inc | ANDA |
| 81033-015 | Nystatin 100000 U/mL Suspension | Kesin Pharma Corporation | ANDA |
| 69315-504 | Nystatin 100000 [USP'U]/mL Suspension | Leading Pharma, LLC | ANDA |
| 69315-307 | Nystatin 100000 [USP'U]/g Ointment | Leading Pharma, LLC | ANDA |
| 69315-306 | Nystatin 100000 [USP'U]/g Powder | Leading Pharma, LLC | ANDA |
| 33342-481 | Nystatin 100000 1/g Ointment | Macleods Pharmaceuticals Limited | ANDA |
| 33342-469 | Nystatin 100000 1/g Cream | Macleods Pharmaceuticals Limited | ANDA |
| 0904-7276 | Nystatin 100000 [USP'U]/mL Suspension | Major Pharmaceuticals | ANDA |
| 72603-491 | Nystatin 100000 [USP'U]/g Powder | Northstar Rx LLC | ANDA |
| 68071-3911 | Nystatin 100000 [USP'U]/g Cream | NuCare Pharmaceuticals, Inc. | ANDA |
| 66267-952 | Nystatin 100000 [USP'U]/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 66267-953 | Nystatin 100000 [USP'U]/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2556 | Nystatin 100000 [USP'U]/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3508 | Nystatin 500000 [USP'U]/1 Tablet, Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3543 | Nystatin 100000 [USP'U]/mL Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4293 | Nystatin 100000 [USP'U]/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 45802-048 | Nystatin 100000 [USP'U]/g Ointment | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-059 | Nystatin 100000 [USP'U]/g Cream | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 0121-0868 | Nystatin 100000 [USP'U]/mL Suspension | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 0121-4810 | Nystatin 100000 [USP'U]/mL Suspension | Pharmaceutical Associates, Inc. | ANDA |
| 0121-0810 | Nystatin 100000 [USP'U]/mL Suspension | Pharmaceutical Associates, Inc. | ANDA |
| 68788-8561 | Nystatin 100000 [USP'U]/mL Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8631 | Nystatin 100000 U/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8690 | Nystatin 500000 [USP'U]/1 Tablet, Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4099 | Nystatin 100000 [USP'U]/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 63187-703 | Nystatin 100000 [USP'U]/g Cream | Proficient Rx LP | ANDA |
| 71205-723 | Nystatin 100000 [USP'U]/g Cream | Proficient Rx LP | ANDA |
| 82804-045 | Nystatin 100000 U/g Cream | Proficient Rx LP | ANDA |
| 71205-575 | Nystatin 500000 [USP'U]/1 Tablet, Coated | Proficient Rx LP | ANDA |
| 71205-437 | Nystatin 100000 [USP'U]/g Ointment | Proficient Rx LP | ANDA |
| 63187-464 | Nystatin 100000 [USP'U]/g Ointment | Proficient Rx LP | ANDA |
| 63187-847 | Nystatin 100000 [USP'U]/g Cream | Proficient Rx LP | ANDA |
| 67296-1519 | Nystatin 100000 U/g Cream | RedPharm Drug, Inc | ANDA |
| 51672-1289 | Nystatin 100000 [USP'U]/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 0093-0983 | Nystatin 500000 [USP'U]/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 13668-595 | Nystatin 100000 U/g Cream | Torrent Pharmaceuticals Limited | ANDA |
| 13668-534 | Nystatin 100000 U/g Ointment | Torrent Pharmaceuticals Limited | ANDA |
| 72578-089 | Nystatin 100000 U/g Ointment | Viona Pharmaceuticals Inc | ANDA |
| 70771-1585 | Nystatin 100000 [USP'U]/g Powder | Zydus Lifesciences Limited | ANDA |
| 70771-1357 | Nystatin 100000 U/g Ointment | Zydus Lifesciences Limited | ANDA |
| 68382-370 | Nystatin 100000 [USP'U]/g Powder | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68999-813 | Nystatin 100000 U/mL Suspension | Chartwell Governmental & Specialty RX, LLC | NDA AUTHORIZED GENERIC |
| 62135-813 | Nystatin 100000 U/mL Suspension | Chartwell RX, LLC | NDA AUTHORIZED GENERIC |
Nystatin recalls
- D-0677-2026 Jul 22, 2026 · Class II · Ongoing
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. - D-0721-2021 Aug 18, 2021 · Class II · Terminated
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. - D-1494-2020 Aug 19, 2020 · Class II · Terminated
Subpotent drug: Out of specification for assay at the 15-month test interval. - D-1060-2020 Apr 1, 2020 · Class II · Terminated
SubPotent Drug: Low out-of-specification results for assay testing. - D-0824-2020 Feb 5, 2020 · Class II · Terminated
Subpotent: Out of specification for assay at the 12-month time point. - D-0865-2018 Jun 13, 2018 · Class III · Terminated
Resuspension problems: Out of specification for appearance and resuspendability.
Frequently asked questions
What is Nystatin used for?
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans .
What are the side effects of Nystatin?
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. See the full label for the complete list.
Who makes Nystatin?
Nystatin is listed by 35 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., American Health Packaging, ATLANTIC BIOLOGICALS CORP..
Has Nystatin been recalled?
The FDA enforcement database lists 6 recalls for Nystatin, most recently D-0677-2026 (class ii): Subpotent Drug: Low out of specification assay results performed during long-term stability testing.