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Nystatin 100000 [USP'U]/g Cream — NDC 51672-1289-01 package photo

Nystatin 100000 [USP'U]/g Cream

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE
NDC 51672-1289-01
🏷️ FDA NDC (as labeled) 51672-1289-1 billing pads the package segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.2004 NADAC Per package$3.01 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4701/unit · Part D plans $0.3523/unit — full pricing hub ↓
Also comes in: 30 g 51672-1289-02
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 51672-1289-1
Product NDC 51672-1289
11-digit billing NDC 51672128901
NCPDP billing unit GM — per gram (weight)
RxCUI 543546
UNII BDF1O1C72E
Application # ANDA064022
SPL Set ID 4d845b3f-ca26-4c47-b424-b6d783cc10e5
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 1993-01-28
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 51672-1289-1 — a 5-4-1 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 package segment → 51672-1289-01. 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 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA064022 (ANDA)
Labeler code51672
First marketedJan 1993
Product typeHuman Prescription Drug
Portfolio889 products on file
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 →
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 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.

12 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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.200 $3.01 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.4701 $7.05 / 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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.268 $0.195
▼ 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nystatin 100000 [USP'U]/g 45802-0059-11 Padagis 1 tube $0.156 AT Availability likely save 22%
Nystatin 100000 [USP'U]/g 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]/gthis 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 100000 [USP'U]/g 00472-0166-15 Actavis 1 tube $0.229 AT Availability likely +14%
Nystatin 100000 [USP'U]/g 45802-0048-11 Padagis 1 tube $0.243 AT Availability likely +21%
Nystatin 100000 [USP'U]/g 69315-0307-15 Leading 1 tube $0.334 AT FDA listed +67%
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 —
Nystatin 100000 [USP'U]/g 63187-0464-15 Proficient 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 72162-2333-02 Bryant 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 50090-3799-00 A-S 1 tube — 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

🏛️
1993
On the market since
Jan 1993
📍
2026
Currently FDA-listed
33 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 51672-1289-01, 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
25.5K
Units reimbursed last 4 qtrs
594.2K
Gross reimbursed last 4 qtrs
$279.3K
Avg / prescription
$10.95
Avg / unit
$0.4701
Latest quarter Q4 2025
4.9KRx
Medicaid pays / g
$0.4701
gross reimbursed
vs
NADAC / g
$0.2004
acquisition cost
=
Spread
+$0.2697
+135% 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 ⓘ
30% FFS 70% MCO
Fee-for-service · 7,565 Rx Managed care · 17,939 Rx
State Medicaid map
Alaska: no data reported AK Maine: 255 units · 18.3 per 100k residents ME Washington: 5,130 units · 65.7 per 100k residents WA Idaho: no data reported ID Montana: 661 units · 58.4 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,005 units · 69.8 per 100k residents MN Wisconsin: 3,810 units · 64.5 per 100k residents WI Michigan: 28,240 units · 281 per 100k residents MI New York: 124,020 units · 634 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,715 units · 64.1 per 100k residents OR Nevada: 960 units · 30.1 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 21,495 units · 171 per 100k residents IL Indiana: 48,478 units · 706 per 100k residents IN Ohio: 58,635 units · 498 per 100k residents OH Pennsylvania: 79,105 units · 610 per 100k residents PA New Jersey: 74,850 units · 806 per 100k residents NJ Massachusetts: 1,185 units · 16.9 per 100k residents MA California: 7,200 units · 18.5 per 100k residents CA Utah: no data reported UT Colorado: 2,280 units · 38.8 per 100k residents CO Nebraska: 1,380 units · 69.8 per 100k residents NE Missouri: 11,760 units · 190 per 100k residents MO Kentucky: 4,950 units · 109 per 100k residents KY West Virginia: 12,705 units · 718 per 100k residents WV Virginia: 9,305 units · 107 per 100k residents VA Maryland: 34,800 units · 563 per 100k residents MD Connecticut: 1,635 units · 45.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,005 units · 13.5 per 100k residents AZ New Mexico: 660 units · 31.2 per 100k residents NM Kansas: 2,100 units · 71.4 per 100k residents KS Arkansas: 1,590 units · 51.8 per 100k residents AR Tennessee: 7,256 units · 102 per 100k residents TN North Carolina: 7,671 units · 70.8 per 100k residents NC South Carolina: 1,095 units · 20.4 per 100k residents SC Delaware: 2,445 units · 237 per 100k residents DE Oklahoma: 1,770 units · 43.7 per 100k residents OK Louisiana: 2,655 units · 58.0 per 100k residents LA Mississippi: 1,065 units · 36.2 per 100k residents MS Alabama: 2,040 units · 39.9 per 100k residents AL Georgia: 3,765 units · 34.1 per 100k residents GA D.C.: 1,365 units · 201 per 100k residents DC Hawaii: no data reported HI Texas: 11,280 units · 37.0 per 100k residents TX Florida: 4,740 units · 21.0 per 100k residents FL
Units reimbursed · per 100k residents
13.5806
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 New Jersey 806 /100k
2 West Virginia 718 /100k
3 Indiana 706 /100k
4 New York 634 /100k
5 Pennsylvania 610 /100k
6 Maryland 563 /100k
7 Ohio 498 /100k
8 Michigan 281 /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 tube51672-1289-02 43,312 Rx · $650,240
1 tube this page51672-1289-01 25,504 Rx · $279,325
Drug total (last 4 qtrs): 68,816 Rx · 2,145,570 units · $929,565 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

0 reports
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
2019 2021 2023 2026 2,483 0
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 NDCDescription Per unit Per pack Marketing startStatus
51672-1289-01 You're viewing this 1 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE $0.2004 / g $3.01 1993-01-28 Active
51672-1289-02 1 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE $0.1559 / g $4.68 1993-01-28 Active

Per g, this pack runs about 29% above the cheapest pack (NDC 51672-1289-02, $0.1559 vs $0.2004 NADAC).

This pack accounts for about 37% 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 51672-1289-01?
NDC 51672-1289-01 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 51672-1289-01 — the 11-digit billing format is 51672128901. 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE Nystatin cream 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 39 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 .)

🤰 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 22 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 155 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 levels 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 Handling 56 words ▾

HOW SUPPLIED Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor. Nystatin Cream USP is supplied in 15 g (NDC 51672-1289-1) and 30 g (NDC 51672-1289-2) 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.

📦 Storage and Handling 15 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.

📋 Description 77 words ▾

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed 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, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment.

Chemical Structure

💬 Information for Patients 93 words ▾

INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: 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. 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.

If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

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