Prescription medicine

Nystatin Brand names: Nystop, Klayesta, Mycostatin, Nyamyc; first approved as Nilstat

Nystatin (Klayesta) is a prescription medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 40 generic labelers, and pharmacies paid $0.175 per gram (Nystatin 100,000 unit/g cream) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the nystatin FDA label on DailyMed (effective May 1, 2026, Torrent Pharmaceuticals Limited); the NDA 50299 record on Drugs@FDA; every nystatin label on DailyMed.

Highlights of the record

FDA label of May 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

Forms and strengths

Cream; suspension; powder; ointment; coated tablet.

On the market

Earliest approval on file: April 14, 1971 Nilstat, Chartwell Molecules; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 59 first July 8, 1964; 32 with a marketed status in Drugs@FDA
Labelers listed (NDC): 41 of which 40 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $0.175 per gram Nystatin 100,000 unit/g cream
Shortage (FDA): No current entry
Recalls by its makers (FDA): 18 since 2013 0 Class I among all firms' recalls; latest September 14, 2026; 2 more by firms not listed as its makers
FAERS reports: 27,281 through July 30, 2026

What is nystatin used for?

From the label: indications and usage
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.

Conditions named in the indications of nystatin's FDA labels, with every medicine labeled for each:

Fungal infections

From other nystatin labels
Fungal infections: INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

FDA pharmacologic class: Polyene Antifungal.

Source: FDA drug label (Nystatin), Torrent Pharmaceuticals Limited, effective May 1, 2026 (SPL set 559b5bd4-3564-4437-8d0a-fa3a972f8b83), via openFDA; the full label on DailyMed

Is there a generic for nystatin (Klayesta)?

The FDA approved the first generic nystatin on July 8, 1964. 59 generic applications are approved; 32 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists nystatin from 40 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1971 earliest approval on file
1964 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for nystatin (Klayesta)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.175 per gram (Nystatin 100,000 unit/g cream), down 3% from $0.180 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Nystatin 100,000 unit/g cream (generic)

$0.204

$0.162

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Klayesta 100,000 unit/g powd	Generic	$0.313 per gram	n/a	-8%
Nyamyc 100,000 unit/g powder	Generic	$0.313 per gram	n/a	-8%
Nystatin 100,000 unit/g cream	Generic	$0.175 per gram	n/a	-3%
Nystatin 100,000 unit/g ointment	Generic	$0.235 per gram	n/a	-4%
Nystatin 100,000 unit/g powd	Generic	$0.313 per gram	n/a	-8%
Nystatin 100,000 unit/mL suspension	Generic	$0.0569 per mL	n/a	-46%
Nystatin 500,000 unit oral tablet	Generic	$0.397 per tablet	$11.91	+3%
Nystop 100,000 unit/g powder	Generic	$0.313 per gram	n/a	-8%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has nystatin been recalled?

The FDA's Enforcement Report lists 20 recalls naming nystatin since 2013: 0 Class I (the most serious), 12 Class II, 7 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of nystatin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
September 14, 2026	Not Yet Classified	SUN PHARMACEUTICAL INDUSTRIES INC	Failed Stability Specifications
June 23, 2026	Class II	Padagis US LLC	Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
July 29, 2021	Class II	PAI Holdings, LLC. dba Pharmaceutical Associates Inc	Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
September 25, 2020	Class III	VistaPharm, Inc.	Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
August 4, 2020	Class II	PAI Holdings, LLC. dba Pharmaceutical Associates Inc	Subpotent drug: Out of specification for assay at the 15-month test interval.
June 23, 2020	Class III	VistaPharm, Inc.	Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
June 10, 2020	Class II	Crown Laboratories	Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
March 19, 2020	Class II	PAI Holdings, LLC. dba Pharmaceutical Associates Inc	SubPotent Drug: Low out-of-specification results for assay testing.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the nystatin label say about other medicines?

The nystatin label names no other medicine on this site. The labels of 1 other medicine name nystatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Check nystatin against other medicines

Source: FDA drug label (Nystatin), Torrent Pharmaceuticals Limited, effective May 1, 2026 (SPL set 559b5bd4-3564-4437-8d0a-fa3a972f8b83), via openFDA; the full label on DailyMed

What do FAERS reports show for nystatin?

The FDA Adverse Event Reporting System holds 27,281 reports that list nystatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,744 are coded as a death and 12,172 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Nausea2,061
Fatigue1,853
Diarrhoea1,839
Pneumonia1,688
Dyspnoea1,535
Off Label Use (a use or a product term, not a reaction)1,479
Vomiting1,408
Drug Ineffective (a use or a product term, not a reaction)1,307

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as nystatin?

8 other medicines are given the same way (oral) and in the same FDA class as nystatin or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Fluconazole	Fungal infections	38 labelers	$0.380 per tablet 200 mg tablet	No current entry
Voriconazole	Fungal infections	21 labelers	$1.88 per tablet 200 mg tablet	A presentation being discontinued
Terbinafine	Fungal infections	22 labelers	$0.143 per tablet 250 mg tablet	No current entry
Posaconazole	Fungal infections	21 labelers	$2.03 per tablet 100 mg tablet	A presentation being discontinued
Griseofulvin	Fungal infections	10 labelers	$3.74 per tablet 250 mg tablet	No current entry
Flucytosine	Fungal infections	9 labelers	n/a	No current entry
Itraconazole	Fungal infections	11 labelers	$0.910 per capsule 100 mg capsule	A presentation being discontinued
Clotrimazole	Fungal infections	3 labelers	$0.292 per troche 10 mg troche	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does nystatin compare with medicines for the same use?

4 side-by-side pages set nystatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Other polyene antifungals: the pharmacologic class, with prices and generics
Nystatin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other