Indications and uses
Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia] albicans and other Candida species.
Nystatin Ointment USP
- Manufacturer
- RPK Pharmaceuticals, Inc.
- Effective date
- 2023-06-07
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 20:50:06
Label at a glance#
ProductNystatin
Active ingredientNYSTATIN
Label structure10 sections
Dosage and administration
Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
For Dermatologic Use Only
Not for Ophthalmic Use
Rx Only
DESCRIPTION
Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:
Molecular Weight 926.13
Molecular Formula C47H75NO17
CLINICAL PHARMACOLOGY
Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.
Nystatin Ointment USP provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.
INDICATIONS AND USAGE
Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.
CONTRAINDICATIONS
Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
PRECAUTIONS
Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.
This preparation is not for ophthalmic use.
ADVERSE REACTIONS
Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.
DOSAGE AND ADMINISTRATION
Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.
This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
HOW SUPPLIED
Product: 53002-8220
NDC: 53002-8220-1 15 g in a TUBE
Nystatin Topical Ointment 100,000 U/GM
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NYSTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-8220-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e893-f424-e053-dadaa90a57ce | Nystatin Ointment USP |
| 53002-8220-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e893-f424-e053-dadaa90a57ce | Nystatin Ointment USP |
| 53002-8220-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e893-f424-e053-dadaa90a57ce | Nystatin Ointment USP |
| 53002-8220-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-e893-f424-e053-dadaa90a57ce | Nystatin Ointment USP |
| 53002-8220-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e893-f424-e053-dadaa90a57ce | Nystatin Ointment USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-8220-1 | Nystatin | 15 g in 1 TUBE | OINTMENT | 15 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-8220 | NYSTATIN OINTMENT [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_0ee89f89-e90d-4706-9fa5-a61b5fde4470.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-048-11 | GM - Gram | 45802-048 | 1ee4e49b-b21e-4d04-a4c2-3f7e3d82747b | 1 | 2012-07-24 |
| 45802-048-35 | GM - Gram | 45802-048 | 7b60fa1f-03d4-4706-a26f-6c900db3cad8 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Nystatin
- LIGHT MINERAL OIL
- PETROLATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53002-8220 | 53002-8220-1 |
| 45802-048 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NYSTATIN | BDF1O1C72E | ACTIB |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062472-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062472-001 | 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.
| 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 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A062472-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1984-02-13 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062472-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A062472-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A062472-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062472-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062472-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062472-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062472-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062472-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062472-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062472-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062472-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062472-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062472-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062472-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062472-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062472-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062472-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062472-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062472-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062472-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062472-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062472-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062472-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062472-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062472-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062472-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062472-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062472-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062472-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062472-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062472-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062472-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062472-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062472-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062472-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062472-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062472-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062472-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062472-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062472-001 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin | NYSTATIN | Padagis Israel Pharmaceuticals Ltd | 6c091c66-2e4d-4412-b7bf-35315dc8152f | 2025-01-23 | Adverse reactions | 45802-048 |
| 54930429-c917-40a2-ad74-449b34b5bd70 | 0ee89f89-e90d-4706-9fa5-a61b5fde4470 | 2023-06-07 | Adverse reactions | 54930429-c917-40a2-ad74-449b34b5bd70 0ee89f89-e90d-4706-9fa5-a61b5fde4470 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.