Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
⚠️
Other active recalls for Nystatin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 23, 2026 — Subpotent Drug: Low out of specification assay results performed during long-term stability testing. (Padagis US LLC)· FDA recall D-0677-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ5
Therapeutic class — intermediate (HIC2)Agents Acting Principally On The Skin
HIC3 codeQ5F
Therapeutic class — specific (HIC3)Topical Antifungals
AHFS code08:14.28.00
AHFS classPolyene Antifungals
FDB label nameNYSTATIN 100,000 UNIT/GM OINT
FDB brand nameNystatin
Legend statusF — Federal legend — prescription drug or device
TE code (Orange Book)AT · RLD · RS
Why two NDCs?
The FDA registers this code as 13668-534-01 — a 5-3-2 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 product segment → 13668-0534-01. 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 classPolyene 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.
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 OINTIngredient 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.
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...
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.
💬 Questions about Nystatin?
Ask a licensed pharmacist directly — free, answered by our team.
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 N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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.
2 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
$0.229
$3.44 / 15 g
Medicaid paysCMS SDUD · 12 mo
$0.4223
$6.33 / 15 g
Medicare drug plans payPart D · Q2 2026
$0.4011
$6.02 / 15 g
NADAC price history (per g) — tap or hover for the price & month
▼ Down 39% 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.
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
🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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 13668-0534-01, 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
1.3K
Units reimbursed last 4 qtrs
33.1K
Gross reimbursed last 4 qtrs
$14K
Avg / prescription
$10.47
Avg / unit
$0.4223
Latest quarter Q4 2025
1.2KRx
Medicaid pays / g
$0.4223
gross reimbursed
vs
NADAC / g
$0.2291
acquisition cost
=
Spread
+$0.1932
+84% 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 ⓘ
13% FFS87% MCO
Fee-for-service · 168 Rx Managed care · 1,166 Rx
State Medicaid map
Units reimbursed · per 100k residents
7.8117
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Massachusetts117 /100k
2South Carolina103 /100k
3Rhode Island58.9 /100k
4Connecticut58.9 /100k
5Virginia55.2 /100k
6Georgia54.1 /100k
7Maryland30.6 /100k
8North Carolina26.9 /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.
Drug total (last 4 qtrs): 4,901 Rx · 155,940 units · $59,067 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 — the ingredient across all brands.
Top reported reactions
Nausea2,063
Fatigue1,856
Diarrhoea1,844
Pneumonia1,689
Dyspnoea1,535
Vomiting1,409
Pain1,287
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Hospitalization12,179
Death3,747
Life-threatening1,753
Disabling743
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.
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.2291 NADAC).
This pack accounts for about 27% of this product's recent Medicaid fills; most go to the 30 gs pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 13668-0534-01?
NDC 13668-0534-01 contains 15 g — 15 g in 1 tube.
What is the difference between NDC 13668-0534-01 and NDC 13668-0534-02?
Both are Nystatin 100000 U/g Ointment — the drug itself is identical. NDC 13668-0534-01 is the 15 g package, while NDC 13668-0534-02 is the 30 g package. Per-g NADAC also differs: $0.2291 here vs $0.2431 for the 30 g pack.
What NDC number is used to bill for this package of Nystatin 100000 U/g Ointment?
Bill NDC 13668-0534-01 — the 11-digit billing format is 13668053401. 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 Nystatin ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
⏱️Dosage and Administration26 words▾
DOSAGE AND ADMINISTRATION Nystatin Ointment Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
⛔Contraindications17 words▾
CONTRAINDICATIONS Nystatin ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
🤒Adverse Reactions40 words▾
ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin ointment preparations 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. )
🤰Pregnancy65 words▾
Pregnancy: Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
🧒Pediatric Use21 words▾
Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. See DOSAGE AND ADMINISTRATION
🧬Clinical Pharmacology156 words▾
CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin is not absorbed from intact skin or mucous membrane. Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.
On repeated subculturing with increasing concentrations of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida ( C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well.
This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
📦How Supplied / Storage and Handling75 words▾
HOW SUPPLIED Nystatin ointment USP, 100,000 units per gram is a pale yellow to yellow color ointment available as follows: NDC 13668-534-01 15 gram tube NDC 13668-534-02 30 gram tube STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Manufactured by: Torrent Pharmaceuticals LTD., Pithampur-454775, INDIA . Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920 8102492 Revised: March 2026 Image
📋Description58 words▾
DESCRIPTION Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum. Image
💬Information for Patients~1 min read▾
INFORMATION FOR PATIENTS Patients using these medications should receive the following information and instructions: 1. The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are 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. Laboratory Tests If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin.
No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. Pregnancy: Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation.
It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. Nursing Mothers It is not known whether nystatin is excreted in human milk.
Caution should be exercised when nystatin is prescribed for a nursing woman. Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. See DOSAGE AND ADMINISTRATION
No label section mentions that — try another word, or open the full label on DailyMed below.
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.
in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
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.
fertility: The natural ability to become pregnant or to father a child.
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.
Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.
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 ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
