Nystatin ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
Nystatin Ointment Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei.
Structural formula:
| Molecular formula | : | C47H75NO17 |
| Molecular weight | : | 926.09 g/mol |
Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum.
Nystatin is not absorbed from intact skin or mucous membrane.
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 concentrations 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.
Nystatin ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
Nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
Nystatin ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
General
Nystatin ointment 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.
Patients using these medications should receive the following information and instructions:
1. The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.
2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.
No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.
Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Safety and effectiveness have been established in the pediatric population from birth to 16 years.
See DOSAGE AND ADMINISTRATION
The frequency of adverse events reported in patients using nystatin ointment preparations 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.)
Nystatin Ointment
Adults and Pediatric Patients (Neonates and Older):
Apply liberally to affected areas twice daily or as indicated until healing is complete.
Nystatin ointment USP, 100,000 units per gram is a pale yellow to yellow color ointment available as follows:
NDC 13668-534-01 15 gram tube
NDC 13668-534-02 30 gram tube
STORAGE
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Manufactured by:
Torrent Pharmaceuticals LTD., Pithampur-454775, INDIA .
Manufactured for:
Torrent Pharma INC., Basking Ridge, NJ 07920
8102492 Revised: March 2026
Nystatin Ointment, USP 15 grams (Tube label)
Nystatin Ointment, USP 15 grams (Carton label)
| Class | Version | Type | Effective |
|---|---|---|---|
| NYSTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13668-534-01 | Nystatin | 15 g in 1 TUBE | OINTMENT | 15 | 8 | |
| 13668-534-02 | Nystatin | 30 g in 1 TUBE | OINTMENT | 30 | 8 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-534-01 | GM - Gram | 13668-534 | c7c9fbc9-6d72-46b7-b92b-242d9c283661 | 1 | 2019-07-02 |
| 13668-534-02 | GM - Gram | 13668-534 | 9f99ba94-8518-4910-a8fd-7ab4e56344af | 1 | 2019-07-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13668-534 | 13668-534-01, 13668-534-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| NYSTATIN | BDF1O1C72E | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211838-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 |
| Application-product | TE code |
|---|---|
| A211838-001 | AT |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | 2019-01-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A211838-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 2019-01-28 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211838-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211838-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211838-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211838-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211838-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211838-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211838-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211838-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211838-001 | AT | 1 | 2680178bc6a6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211838-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A211838-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A211838-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A211838-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A211838-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A211838-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211838-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A211838-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A211838-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A211838-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A211838-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A211838-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A211838-001 | AT | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A211838-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211838-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A211838-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A211838-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211838-001 | AT | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211838-001 | AT | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin | NYSTATIN | Torrent Pharmaceuticals Limited | 4949dea7-d2b9-4e0d-974a-39408fa174ba | 2026-05-08 | Adverse reactions | 13668-534-01 13668-534-02 13668-534 13668053402 13668053401 b5c975a5-4d7a-4177-b1e2-524bad92a5fb 4949dea7-d2b9-4e0d-974a-39408fa174ba |
Adverse event summaries are temporarily unavailable. Other product information remains available.