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 (100,000 units/g)
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Effective date
- 2013-10-02
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:18:05
Label at a glance#
ProductNystatin
Active ingredientNYSTATIN
Label structure10 sections
Dosage and administration
Nystatin Ointment USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx Only
DESCRIPTION
Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.
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 of undetermined structural formula 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 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Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
ADVERSE REACTIONS
Nystatin is virtually nontoxic 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 the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
HOW SUPPLIED
Nystatin Ointment USP 100,000 units/g
15 g tube (0.53 oz)
Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.
Manufactured by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA
FORM NO. 0166
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Rev. 1/06
VC2752
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 |
|---|---|---|---|---|---|
| 53217-022-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7651-f424-e053-dadaa90a57ce | NYSTATIN OINTMENT USP (100,000 units/g) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-022-01 | Nystatin | 15 g in 1 TUBE | OINTMENT | 15 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53217-022-01 | GM - Gram | 53217-022 | 1a090c45-fab6-48e7-8f24-d8f78c47c49f | 1 | 2015-10-02 |
| 0472-0166-15 | GM - Gram | 0472-0166 | 425f994d-fab4-43bd-885c-5c95b3fc668e | 1 | 2012-07-24 |
| 0472-0166-30 | GM - Gram | 0472-0166 | ce406d70-fd20-477a-82fe-957542c06280 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NYSTATIN | ACTIVE INGREDIENT | BDF1O1C72E | 1 | |
| NYSTATIN | ACTIVE MOIETY | BDF1O1C72E | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 |
Products#
Every source-derived product name is available through these pages.
- Nystatin
- PETROLATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53217-022 | 53217-022-01 |
| 0472-0166 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NYSTATIN | BDF1O1C72E | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg |
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 |
|---|---|---|---|---|---|---|---|
| A062840-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062840-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062840-001 | NYSTATIN | 100,000 UNITS/GM | OINTMENT / TOPICAL | AT | 1987-11-13 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A062840-001 | AT | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A062840-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A062840-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A062840-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062840-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062840-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062840-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062840-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062840-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062840-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062840-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062840-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062840-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062840-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062840-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062840-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062840-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062840-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062840-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062840-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062840-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062840-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062840-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062840-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062840-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062840-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062840-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062840-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062840-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062840-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062840-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062840-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062840-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062840-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062840-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062840-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062840-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062840-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062840-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062840-001 | AT | 1 | 3a93d1ddd44b… |
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 | Actavis Pharma, Inc. | aee7ce4c-8cc6-4446-a4d7-63bc4773066f | 2023-10-30 | Adverse reactions | 0472-0166 |
| 342bbf92-0160-4f92-b1ce-98cedd5fd6d5 | aae5b1f0-f852-4b64-a5ef-6f8334ae2b4d | 2013-10-02 | Adverse reactions | 342bbf92-0160-4f92-b1ce-98cedd5fd6d5 aae5b1f0-f852-4b64-a5ef-6f8334ae2b4d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.