Nystatin Topical Powder — Powder

Overview

Brand name

Nystatin Topical Powder

Generic name

Nystatin Topical Powder

Dosage form

Powder

Route

Topical

Marketing category

ANDA · ANDA

Labeler

Epic Pharma, LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

6

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Nystatin	100000 U/g	261178	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Powder

Route of administration

Topical

Presentations

8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Polyene Antifungal [EPC]	EPC	All 12 members
Polyenes [CS]	CS	All 13 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

210532

Application type

ANDA · Abbreviated New Drug Application

Approval date

April 30, 2018

Sponsor

EPIC PHARMA LLC

Products on application

1

Submissions recorded

1

Products approved under application 210532.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
210532-001	KLAYESTA	POWDER		NYSTATIN	Prescription	AT

Therapeutic equivalence

Source: Orange Book

TE code

AT

Reference Listed Drug

No

Reference Standard

No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 210532.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	April 30, 2018	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230810). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20230810 HUMAN PRESCRIPTION DRUG · 20180502

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

CONTRAINDICATIONS Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin topical powder 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 .)

Description

openFDA Drug Labeling

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin. structure-formula.jpg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Nystatin topical powder, USP is off-white to light yellow powder, and is supplied as 100,000 units nystatin per gram in plastic squeeze bottles. 15 g (NDC 42806-185-15) 30 g (NDC 42806-185-30) 60 g (NDC 42806-185-60)

Adverse event reports

Source: openFDA FAERS

27,387

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: NYSTATIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
42806-178-15	42806-178	Epic Pharma, LLC	15 g in 1 BOTTLE (42806-178-15)	May 2, 2018
42806-178-30	42806-178	Epic Pharma, LLC	30 g in 1 BOTTLE (42806-178-30)	May 2, 2018
42806-178-60	42806-178	Epic Pharma, LLC	60 g in 1 BOTTLE (42806-178-60)	May 2, 2018
42806-185-15	42806-185	Epic Pharma, LLC	15 g in 1 BOTTLE (42806-185-15)	April 14, 2023
42806-185-30	42806-185	Epic Pharma, LLC	30 g in 1 BOTTLE (42806-185-30)	April 14, 2023
42806-185-60	42806-185	Epic Pharma, LLC	60 g in 1 BOTTLE (42806-185-60)	April 14, 2023
42806-178	42806-178	Epic Pharma, LLC	—	May 2, 2018
42806-185	42806-185	Epic Pharma, LLC	—	April 14, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.