NDC 00713-0678-15 — Nystatin 100000 [USP'U]/g Cream

🆔 Identity & classification

FDA NDC (as labeled) 0713-0678-15

Product NDC 0713-0678

11-digit billing NDC 00713067815

NCPDP billing unit GM — per gram (weight)

RxCUI 543546

UNII BDF1O1C72E

Application # ANDA061966

SPL Set ID ec1b52af-d38e-eba1-e63c-dba4341d3af2

Established class (EPC) Polyene Antifungal

Chemical class Polyenes

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-04-01

Route TOPICAL

Dosage form CREAM

Substance NYSTATIN

GPI-14 90150080003710

GPI class Nystatin

GCN Seq No 007282

GCN 30140

HICL code 004129

Ingredient (HICL) Nystatin

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q5F

Therapeutic class — specific (HIC3) Topical Antifungals

AHFS code 08:14.28.00

AHFS class Polyene Antifungals

FDB label name NYSTATIN 100,000 UNIT/GM CREAM

FDB brand name Nystatin

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AT · RLD · RS

Why two NDCs? The FDA registers this code as 0713-0678-15 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00713-0678-15. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Polyene Antifungal class.

Pharmacologic class Polyene Antifungal

Drug family (ATC) Antibiotics, Antibiotics, Antibiotics

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCosette Pharmaceuticals, Inc.

Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC

FDA applicationANDA061966 (ANDA)

Labeler code00713

First marketedApr 2015

Product typeHuman Prescription Drug

Portfolio99 products on file

🔎 All NDCs from Cosette Pharmaceuticals, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NYSTATIN 100,000 UNIT/GM CREAM Ingredient Nystatin

📖 What it is MedlinePlus · NLM

Topical nystatin is used to treat fungal infections of the skin. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Nystatin treats yeast infections caused by Candida. Depending on the form you're given, it can clear up a yeast infection in your mouth (thrush), on your skin, or in your gastroint...
Shake it well, then swish it around your entire mouth — hold it there as long as you comfortably can before swallowing. If you're giving it to an infant, use the dropper to place h...
How do I use the oral suspension correctly?
Nystatin is generally very well tolerated. The most common complaints with the topical forms are minor — things like burning, itching, or redness right where you apply it. These ar...

📖 Read our full Nystatin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

UNII 03J11K103C
Algeldrate is an aluminum-based compound that neutralizes stomach acid. It's used in antacid formulations as the active therapeutic ingredient, though classified here as an excipient in combination products where it works alongside other components to relieve heartburn and indigestion.
UNII 867H4YOZ8Z
A waxy compound made from plant or animal oils mixed with ethylene oxide. It helps oils and water blend together in creams and lotions, and makes the product easier to spread and absorb.
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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	$0.200	$3.01 / 15 g
Medicaid paysCMS SDUD · 12 mo	$0.4722	$7.08 / 15 g
Medicare drug plans payPart D · Q2 2026	$0.3523	$5.28 / 15 g

NADAC price history (per g) — tap or hover for the price & month

▼ Down 19% over the last 24 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Nystatin 100000 [USP'U]/g 45802-0059-11	Padagis	1 tube	$0.156	AT	Availability likely	save 22%
Nystatin 100000 [USP'U]/gthis 00713-0678-15	Cosette	1 tube	$0.200	AT	Availability likely	—
Nystatin 100000 U/g 13668-0595-01	Torrent	15 g	$0.200	AT	Availability likely	—
Nystatin 100000 1/g 33342-0469-15	Macleods	1 tube	$0.200	AT	Availability likely	—
Nystatin 100000 [USP'U]/g 51672-1289-01	Sun	1 tube	$0.200	AT	Availability likely	—
Nystatin 100000 [USP'U]/g 59651-0907-14	Aurobindo	1 tube	$0.200	AT	Availability likely	—
Nystatin Cream 100000 [USP'U]/g 00316-0221-15	Crown	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 50090-2763-00	A-S	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 50090-2854-00	A-S	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 50090-3772-00	A-S	1 tube	—	AT	FDA listed	—
Nystatin 100000 U/g 50090-7303-00	A-S	15 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 63187-0703-15	Proficient	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 63187-0847-15	Proficient	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 63629-8694-01	Bryant	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 63629-8695-01	Bryant	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 66267-0952-30	NuCare	30 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 66267-0953-15	NuCare	15 g	—	AT	FDA listed	—
Nystatin 100000 U/g 67296-1519-01	RedPharm	15 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 68071-2556-05	NuCare	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 68071-3911-05	NuCare	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 68071-4293-03	NuCare	30 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 68788-4099-01	Preferred	1 tube	—	AT	FDA listed	—
Nystatin 100000 U/g 68788-8631-01	Preferred	15 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 71205-0723-30	Proficient	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 71335-2830-01	Bryant	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 72162-1385-02	Bryant	1 tube	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 72162-2496-02	Bryant	1 tube	—	AT	FDA listed	—
Nystatin 100000 U/g 72162-2576-02	Bryant	15 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 72189-0278-15	DIRECT	15 g	—	AT	FDA listed	—
Mycostatin 100000 [USP'U]/g 72189-0408-15	Direct_Rx	15 g	—	AT	FDA listed	—
Nystatin 100000 U/g 82804-0045-15	Proficient	15 g	—	AT	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2015

On the market since

Apr 2015

📍

2026

Currently FDA-listed

11 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

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?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00713-0678-15, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

39.8K

Units reimbursed last 4 qtrs

887.9K

Gross reimbursed last 4 qtrs

$419.2K

Avg / prescription

$10.54

Avg / unit

$0.4722

Latest quarter Q4 2025

9.1KRx

Medicaid pays / g

$0.4722

gross reimbursed

vs

NADAC / g

$0.2004

acquisition cost

=

Spread

+$0.2718

+136% vs cost

What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

35% FFS 65% MCO

Fee-for-service · 14,071 Rx Managed care · 25,686 Rx

State Medicaid map

Units reimbursed · per 100k residents

9.81,542

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Vermont 1,542 /100k

2 Kentucky 893 /100k

3 West Virginia 665 /100k

4 Michigan 561 /100k

5 Texas 552 /100k

6 New Mexico 517 /100k

7 New York 516 /100k

8 New Jersey 473 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 tube00713-0678-31 119,938 Rx · $1,593,915

1 tube this page00713-0678-15 39,757 Rx · $419,225

Drug total (last 4 qtrs): 159,695 Rx · 5,049,202 units · $2,013,140 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nystatin — the program that covers self-administered drugs. 22 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nystatin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$16.29M

Claims incl. refills

853.7K

Beneficiaries

614.3K

Spend / beneficiary

$26.52

Spend / claim

$19.08

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Nystatin (this brand).

Top reported reactions

Nausea1,979

Diarrhoea1,762

Fatigue1,762

Pneumonia1,633

Dyspnoea1,472

Vomiting1,370

Pain1,217

Reporter sex

Serious outcomes

Death3,621

Life-threatening1,743

Disabling721

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
00713-0678-15 You're viewing this	1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE	$0.2004 / g	$3.01	2015-04-01	Active
00713-0678-31	1 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE	$0.1559 / g	$4.68	2015-04-01	Active

Per g, this pack runs about 29% above the cheapest pack (NDC 00713-0678-31, $0.1559 vs $0.2004 NADAC).

This pack accounts for about 25% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00713-0678-15?

NDC 00713-0678-15 is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.

What NDC number is used to bill for this package of Nystatin 100000 [USP'U]/g Cream?

Bill NDC 00713-0678-15 — the 11-digit billing format is 00713067815. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 38 words ▾

INDICATIONS AND USAGE Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

⏱️ Dosage and Administration 24 words ▾

DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

🤒 Adverse Reactions 58 words ▾

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream 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 . ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 63 words ▾

Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

🧒 Pediatric Use 23 words ▾

Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION . )

🧓 Geriatric Use 54 words ▾

Geriatric Use Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 2 words ▾

CLINICAL PHARMACOLOGY

📦 How Supplied / Storage and Handling 61 words ▾

HOW SUPPLIED Nystatin Cream, USP is a smooth yellow cream. Nystatin Cream, USP is supplied in 15 g (NDC 0713-0678-15) and 30 g (NDC 0713-0678-31) tubes providing 100,000 USP Nystatin units per gram. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 03/2022 8-0678CPLNC2 VC7625

📋 Description 76 words ▾

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: C 47 H 75 NO 17 Molecular Weight: 926.13 Nystatin Cream, USP is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in a cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben, propylparaben, and sodium hydroxide. image description

💬 Information for Patients 96 words ▾

INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: 1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is 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.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

mucocutaneous: Involving both the skin and the moist linings of the body, such as the mouth, eyes, or nose.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Nystatin Cream NDCsSame ingredient 🏭 All Cosette labeler NDCsLabeler code 00713 📚 All Polyene Antifungal NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Antifungals.

Nystatin/Triamcinolone Acet 00168-0081-15 Miconazole Nitrate 00316-0225-15 Gentian Violet 00395-1003-92 Tolnaftate 00536-1315-43

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.