![Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream — NDC 00316-0223-30 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54aae5d3-e482-4da0-a1b2-0ed70e6c2915&name=Nystatin+and+TA+30+gram+carton.jpg)
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream — NDC 0316-0223-30 (Billing 00316-0223-30)
This is a package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream from Crown Laboratories, marketed since Jan 2018 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0316-0223-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0316 labeler · 0223 product · 30 package
- Package marketed since
- Jan 2, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0303160223303
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048529
- GCN: 14007
- GPI-14 (Medi-Span): 90159902253700
- HICL (First Databank): 003161
- AHFS class code: 48:10.08.00
- RxCUI (RxNorm): 1053753
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats cutaneous candidiasis, which is a yeast infection of the skin. The nystatin fights the yeast. The triamcinolone calms redness and itching, so you may feel relief faster t...
- Usually you apply it to the affected skin twice a day, morning and evening. Massage the cream in gently, or spread the ointment as a thin film. Follow your prescriber's directions.
- No. Do not use airtight (occlusive) dressings over it. They can greatly increase how much steroid your skin absorbs.
- Most people have few problems. Some may notice burning, itching, dryness, irritation or acne-like bumps. Let your doctor know if skin thinning, stretch marks or lighter patches app...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00316-0223-15 0316-0223-15 Main listing | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | 2018-01-02 | — | Active |
| 00316-0223-30 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | 2018-01-02 | — | Active |
| 00316-0223-60 0316-0223-60 | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | 2018-01-02 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream?
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5ZA2S6B08X
Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII Q504PL8E0V
A waxy emulsifier blend derived from sorbitan and polyethylene glycol. It helps mix oil and water-based ingredients together and is commonly used in creams and ointments to create a smooth, uniform texture.
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UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII X045WJ989B
Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Crown Laboratories labeler code 00316
- TRIDERM Triamcinolone Acetonide .25 mg/g Cream NDC 0316-0165-15
- TRIDERM Triamcinolone Acetonide 1 mg/g Cream NDC 0316-0170-01
- TRIDERM Triamcinolone Acetonide 5 mg/g Cream NDC 0316-0175-15
- Hydrocortisone 10 mg/g Cream NDC 0316-0186-01
- Hydrocortisone 25 mg/g Cream NDC 0316-0193-16
- Nystatin Cream 100000 [USP'U]/g Cream NDC 0316-0221-15
- Desenex MICONAZOLE NITRATE 20 mg/g Powder NDC 0316-0225-01
- Mineral Ice Pain Relieving Menthol 20 mg/g Gel NDC 0316-0226-08
- PanOxyl benzoyl peroxide 58.7 mg/g Cream NDC 0316-0227-06
- PanOxyl benzoyl peroxide 100 mg/g Cream NDC 0316-0228-01
- Sarna Pramoxine Hydrochloride 10 mg/mL Lotion NDC 0316-0230-12
- Sarna Pramoxine Hydrochloride, Menthol .5 mg/1000mL; 10 mg/1000mL Lotion NDC 0316-0234-12
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Cream is 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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 ). Nystatin and Triamcinolone Acetonide Cream should not be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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.
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. To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/
🤰 Pregnancy ▾
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.
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.
🧒 Pediatric Use ▾
Pediatric Use In clinical studies of a limited number of pediatric patients ranging from two months through 12 years, nystatin and triamcinolone acetonide cream formulation cleared or significantly ameliorated the disease state in most patients. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.
Chronic corticosteroid therapy may interfere with the growth and development of children.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Nystatin Nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. The binding process renders the cell membrane incapable of functioning as a selective barrier. Nystatin provides specific anticandidal activity to Candida albicans and other Candida species, but is not active against bacteria, protozoa, trichomonads, or viruses.
Nystatin is not absorbed from intact skin or mucous membranes. Triamcinolone Acetonide Triamcinolone acetonide is primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. The pharmacologic effects of the topical corticosteroids are well known; however, the mechanisms of their dermatologic actions are unclear.
Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ).
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile. Nystatin and Triamcinolone Acetonide During clinical studies of mild to severe manifestations of cutaneous candidiasis, patients treated with nystatin and triamcinolone acetonide showed a faster and more pronounced clearing of erythema and pruritus than patients treated with nystatin or triamcinolone acetonide alone.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Nystatin and Triamcinolone Acetonide Cream is supplied in: 15 gram tube NDC 0316-0223-15 30 gram tube NDC 0316-0223-30 60 gram tube NDC 0316-0223-60
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 REVISED: OCT 2019 Printed in USA P9528.02
📋 Description ▾
DESCRIPTION Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal like odor, practically insoluble in water and in alcohol.
Structural formula: Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white crystalline powder is practically insoluble in water, and very soluble in alcohol. Structural formula: Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a yellow to tan color.
Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. Nystatin TA
💬 Information for Patients ▾
Information for the Patient Patients using this medication should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION ). Patients should report any signs of local adverse reactions.
When using this medication in the inguinal area, patients should be advised to apply the cream sparingly and to wear loose fitting clothing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Patients should be advised on preventive measures to avoid reinfection.
🍼 Nursing Mothers ▾
Nursing Mothers 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.
📄 Package Label / Principal Display Panel ▾
Nystatin and Triamcinolone Acetonide Cream 30 gram tube NDC 0316-0223-30 Nystatin and Triamcinolone Acetonide Cream USP 30 grams For external use only. Not for ophthalmic use. Rx Only P9508.01 30gtube
Nystatin and Triamcinolone Acetonide Cream 30 gram carton NDC 0316-0223-30 Nystatin and Triamcinolone Acetonide Cream USP 30 grams For external use only. Not for ophthalmic use. Rx Only P9520.02 Nystatin and TA 30 gram carton
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |