Quick answers
- What is Nystatin and triamcinolone acetonide used for?
- The FDA-approved label (Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., July 7, 2025) says: “Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Nystatin and triamcinolone acetonide?
- The “Adverse Reactions” section of the FDA label (Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., July 7, 2025) begins: “A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nystatin and triamcinolone acetonide have a boxed warning?
- No. None of the 35 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nystatin and triamcinolone acetonide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nystatin and triamcinolone acetonide been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 17, 2019 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Nystatin and triamcinolone acetonide?
- 17 companies list prescription products of Nystatin and triamcinolone acetonide in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and Macleods Pharmaceuticals Limited.
What Nystatin and triamcinolone acetonide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (cream, topical), Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 35 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 35 FDA labels for this medicine have a boxed warning.
Nystatin and triamcinolone acetonide side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur.
Read more of this section
The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
Nystatin and triamcinolone acetonide dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Nystatin and Triamcinolone Acetonide Cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests). A thin film of Nystatin and Triamcinolone Acetonide Ointment is usually applied to the affected areas twice daily in the morning and evening.
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The preparation should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests). Nystatin and Triamcinolone Acetonide Cream and Ointment should not be used with occlusive dressings.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
Nystatin and triamcinolone acetonide in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Category C There are no teratogenic studies with combined nystatin and triamcinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Read more of this section
Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
Nystatin and triamcinolone acetonide and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is not known whether any component of this preparation is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised during the use of this preparation by a nursing woman.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
When Nystatin and triamcinolone acetonide should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
Nystatin and triamcinolone acetonide overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General); however, acute overdosage and serious adverse effects with dermatologic use are unlikely.
— FDA label: Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Cream · Ointment |
|---|---|
| Route | Topical |
| Prescription products | 36 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| nystatin 100000 USP units/g · triamcinolone acetonide 0.1% cream | Generic | $0.1869–$0.2914 per gram 14 packages, lowest to highest |
| nystatin 100000 USP units/g · triamcinolone acetonide 0.1% ointment | Generic | $0.2266–$0.3554 per gram 15 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack12 products
- NuCare Pharmaceuticals, Inc.3 products
- Macleods Pharmaceuticals Limited2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Preferred Pharmaceuticals Inc.2 products
- Alembic Pharmaceuticals Inc.2 products
- Encube Ethicals, Inc.1 product
- Torrent Pharmaceuticals Limited1 product
- Preferred Pharmaceuticals Inc., USA1 product
- Lupin Pharmaceuticals, Inc.1 product
- Crown Laboratories1 product
- Remedyrepack Inc.1 product
- Viona Pharmaceuticals Inc1 product
- Zydus Lifesciences Limited1 product
- Alembic Pharmaceuticals Limited1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (15)
- ANDA062364Sun Pharma Canada · December 22, 1987
- ANDA063305Sun Pharma Canada · March 29, 1993
- ANDA208300Glenmark Pharms Ltd · June 23, 2016
- ANDA208136Glenmark Pharms Ltd · October 24, 2016
- ANDA207380Padagis Israel · December 20, 2016
- ANDA207741DR Reddys · January 31, 2017
- ANDA208479Padagis Israel · August 14, 2017
- ANDA207730Crown Labs Inc · December 26, 2017
- ANDA208205Lupin · May 31, 2018
- ANDA207764Zydus Lifesciences · November 8, 2018
- ANDA213142Torrent · July 14, 2020
- ANDA214090Alembic · March 31, 2021
- ANDA214751Macleods Pharms · August 17, 2021
- ANDA214186Alembic · March 4, 2022
- ANDA214181Macleods Pharms · July 13, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 17, 2019 · Class III · Terminated · D-1518-2019
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 IN — Lupin Pharmaceuticals Inc.
-
March 28, 2017 · Class II · Terminated · D-0676-2017
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263- — Taro Pharmaceuticals U.S.A., Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1053697, 1053753 |
|---|---|
| SPL set ID of the quoted label | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e |
| FDA labels (SPL) | 35 |
| FDA applications | 15 ANDA |
| Active ingredients (FDA) | NYSTATIN / TRIAMCINOLONE ACETONIDE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Bryant Ranch PrepackMaker or distributor
- NuCare Pharmaceuticals, Inc.Maker or distributor
- Macleods Pharmaceuticals LimitedMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nystatin and Triamcinolone Acetonide, Sun Pharmaceutical Industries, Inc., effective July 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →