NYSTATIN

Manufacturer: Leading Pharma, LLC | Lyne Laboratories, Inc
Effective date: 2024-04-18
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:05:12

Label at a glance#

ProductNYSTATIN

Active ingredientNYSTATIN

Label structure7 sections

Indications and uses

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.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1.
Structural formula:

Chemical-structure

Nystatin topical powder is for dermatologic use.
Nystatin topical powder contains 100,000 nystatin units per gram dispersed in talc.

CLINCAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS

PRECAUTIONS SECTION

General

PRECAUTIONS SECTION

Nystatin topical powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens

HOW SUPPLIED

HOW SUPPLIED SECTION

Nystatin topical powder is supplied as 100,000 units nystatin per gram in plastic squeeze bottles:

15g (NDC 69315-306-15)

30g (NDC 69315-306-30)

60g (NDC 69315-306-60)

STORAGE

Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F).

Keep tightly closed.

Manufactured for:

Leading Pharma LLC, Fairfield, NJ 07004

Manufactured by:

Lyne Laboratories, Inc. Brockton, MA 02301

R1-01/20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container-100000unit15gmContainer-100000unit30gmContainer-100000unit60gm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
646456	nystatin 100,000 UNT/GM Topical Powder	PSN	5
646456	nystatin 100 UNT/MG Topical Powder	SCD	5
646456	nystatin 100,000 UNT/GM Topical Powder	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NYSTATIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e29fe634-dc25-094c-c77f-5d09c3eceb3e	Product name	5	20260107
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e57b6340-9387-3f9a-7307-511c81791375	Product name	3	20221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7	Product name	5	20210614
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97a	Product name	3	20180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69315-306-15	NYSTATIN	15 g in 1 BOTTLE, PLASTIC	POWDER	15	5
69315-306-30	NYSTATIN	30 g in 1 BOTTLE, PLASTIC	POWDER	30	5
69315-306-60	NYSTATIN	60 g in 1 BOTTLE, PLASTIC	POWDER	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69315-306	NYSTATIN POWDER [LEADING PHARMA, LLC]	5	Current NDC, Legacy NDC, 3 package rows	20240613_089e6444-2bd1-443e-acf0-dfeaa69faef9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-306-15	GM - Gram	69315-306	bfc4241a-8f2c-446c-af33-61487218ee6d	1	2018-05-09
69315-306-30	GM - Gram	69315-306	626322eb-727d-43ee-9421-13cb7344dfb0	1	2018-05-09
69315-306-60	GM - Gram	69315-306	96a7dca3-3da5-41cf-8c86-89f8639df1ec	1	2018-05-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NYSTATIN
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69315-306	69315-306-15, 69315-306-30, 69315-306-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NYSTATIN	BDF1O1C72E	ACTIB
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208838-001	NYSTATIN	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT		2017-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208838-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208838-001	NYSTATIN	100,000 UNITS/GM	POWDER / TOPICAL	AT	2017-05-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208838-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208838-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208838-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208838-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208838-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208838-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208838-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208838-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208838-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208838-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208838-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208838-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208838-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208838-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208838-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208838-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208838-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208838-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208838-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208838-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208838-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208838-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208838-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208838-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208838-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208838-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208838-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208838-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208838-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208838-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208838-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208838-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208838-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208838-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208838-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208838-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208838-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208838-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208838-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208838-001	AT	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NYSTATIN	NYSTATIN	Leading Pharma, LLC	089e6444-2bd1-443e-acf0-dfeaa69faef9	2024-04-18		Exact identifier ndc (package): 69315-306-60 ndc (package): 69315-306-15 ndc (package): 69315-306-30 ndc (product): 69315-306 ndc11 (package): 69315030660 ndc11 (package): 69315030630 ndc11 (package): 69315030615 spl id: 408ac13e-825a-44b1-b8cd-d52cbb0185d0 spl set id: 089e6444-2bd1-443e-acf0-dfeaa69faef9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.