FDA-filed SPL labeling · retrieved through openFDA

Nystatin

Nystatin is an antifungal medication used to treat Candida (yeast) infections of the skin, mouth, and gastrointestinal tract, available in topical and oral forms.

Brand names Mycostatin Oral TabletsNilstat Oral TabletsNilstat SuspensionNystex SuspensionBio-Statin +5 more
Drug class ⓘ Polyene Antifungal
Rx Forms 5 Routes Topical · Oral · Oral; Topical · Oral, Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 70 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 9, 2025
Clinical labels in scope ⓘ70
AvailabilityRx
Earliest approval/marketing year ⓘ1964
FDA-listed product records ⓘ252
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026 🚨Recall on record
Other forms & routes:
Topical
⭐ Nystatin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Nystatin is a well-established antifungal that targets Candida yeast infections in the mouth, on the skin, and in the gastrointestinal tract, depending on the form. It works locally and is generally well tolerated, with only minor skin reactions reported in most users. Use the exact form your prescriber prescribed and finish the full course to prevent the infection from coming back.
How we write & review this content — our editorial policy →

📖 Nystatin: Patient Information Guide

A plain-language walkthrough of Nystatin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Nystatin is an antifungal used across several forms to treat Candida yeast infections in different parts of the body.

  • Topical creams (Mycostatin, Nystatin Cream, Nystatin): treat Candida infections of the skin and mucous membranes
  • Nystatin ointment: treats cutaneous or mucocutaneous Candida infections of the skin
  • Topical powders (Klayesta, Nyamyc, Nystop, Nystatin Topical Powder, Nystatin): treat skin and mucocutaneous Candida infections; particularly useful for moist lesions
  • Nystatin Oral Suspension and Nystatin oral suspension: treat candidiasis (yeast infection) in the mouth and oral cavity
  • Nystatin tablets: treat non-esophageal mucous membrane gastrointestinal candidiasis (Candida infections of the GI tract lining, excluding the esophagus)
⚙️How it works▾

Nystatin targets the cell membrane of Candida fungi. It binds to sterols — structural fats in the membrane — and punches holes in it. This causes the fungal cell's contents to leak out, which kills the organism or stops it from growing. Because human cells use different sterols, nystatin selectively harms fungal cells. It does not work against bacteria, viruses, or protozoa.

Nystatin is not absorbed through intact skin or mucous membranes, so topical forms act locally. Candida albicans generally does not develop resistance to nystatin during treatment, though some other Candida species (such as C. tropicalis and C. krusei) can become resistant — though this resistance tends to reverse once the drug is stopped.

💊How it's taken▾

Dosing and how you take nystatin depends entirely on the form your prescriber chooses.

  • Oral suspension: Taken four times a day; swish in the mouth as long as possible before swallowing. For infants, use the dropper to place half the dose in each side of the mouth.
  • Tablets: Taken three times a day by mouth.
  • Topical creams and ointment: Applied to the affected skin area twice daily.
  • Topical powders: Dusted onto affected areas two or three times daily; for foot infections, also apply inside footwear.

For all forms, keep treating for at least 48 hours after symptoms clear to help prevent the infection from returning. Follow your prescriber's exact instructions.

🤒Side effects — in detail▾

Side effects with nystatin are uncommon — reported in fewer than 1 in 1,000 users of topical forms.

  • Burning at the application site
  • Itching
  • Skin rash
  • Eczema (skin inflammation)
  • Pain on application
  • Allergic reactions
  • Nausea or gastrointestinal upset (reported with very high oral doses only)

If you develop a significant rash, swelling, or signs of a serious allergic reaction, stop using nystatin and contact your doctor right away.

⚠️Warnings & precautions▾
  • Allergy: Do not use nystatin if you've had an allergic reaction to it or any ingredient in the product.
  • Right form for the right place: Topical creams, ointments, and powders are for skin use only — never use them in the eyes, take them by mouth, or use them vaginally. Each form is approved only for its indicated route.
  • Resistance: Some Candida species can become resistant during treatment. If your infection isn't improving, let your prescriber know.
🔀What it interacts with▾

The FDA label for nystatin does not identify specific drug, food, or supplement interactions.

    This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

    📋Before taking it▾
    • Tell your prescriber if you have ever had an allergic reaction to nystatin or to any ingredient in the preparation — using it again could cause a serious reaction
    • Topical nystatin forms are safe for neonates (newborns) and older children as well as adults, but always follow the specific directions for age group
    • Do not use topical nystatin in the eyes, take it orally (unless it is the oral form), or use it vaginally — it is not approved for those routes
    🚑If you take too much▾

    Oral doses of nystatin much higher than what is typically prescribed have caused nausea and gastrointestinal upset. If you think someone has taken too much, contact a poison control center or seek medical attention promptly.

    📡Pharmacodynamics — effects in the body▾

    Nystatin is both fungistatic (stops fungal growth) and fungicidal (kills fungi) against a wide range of Candida and other yeast-like fungi. It works by disrupting the fungal cell membrane, causing contents to leak out. It has no meaningful activity against bacteria, viruses, or protozoa, so it won't treat bacterial infections.

    🔬Pharmacokinetics — how your body processes it▾

    Nystatin is not absorbed through intact skin or mucous membranes. This means topical forms work locally at the site of application and do not enter the bloodstream in significant amounts, which limits systemic (whole-body) side effects from topical use.

    📦How to store it▾

    Nyamyc® (Nystatin Topical Powder, USP) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Avoid excessive heat (40°C/104°F). Keep out of reach of children.

    📄 Written from Nystatin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

    20

    Supplements & herbs that interact with Nystatin

    20 supplements and herbal products have documented interactions with Nystatin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

    Severity mix
    • Major · 1
    • Moderate · 7
    • Minor · 12
    ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate TRAGACANTH Moderate +12 more
    Every supplement checked against Nystatin — ranked by severity The full interaction hub: 1 major · 7 moderate · 12 minor · every one linked to its full report. Check Nystatin against your exact supplements

    Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

    🩺 Pharmacist Counseling Corner

    Quick, plain-English answers to the questions patients ask most about Nystatin — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly is nystatin used for? ▾
    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 gastrointestinal tract. The cream, ointment, and powder go on the skin; the suspension is swished in the mouth; and the tablet treats the GI tract lining. Each form is designed for a specific area, so use only what was prescribed for you.
    How do I use the oral suspension correctly? ▾
    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 half the dose in each side of the mouth, and try not to feed them for about 5 to 10 minutes after. Take it four times a day and keep going for at least two full days after your symptoms are gone, even if you feel better sooner.
    What side effects should I watch for? ▾
    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 are usually mild and go away as your infection clears. If you notice a more serious reaction like widespread rash, significant swelling, or trouble breathing, stop using it and call your doctor or seek care right away — that could signal an allergic reaction.
    Can I stop using it once my symptoms improve? ▾
    It's tempting to stop once you feel better, but it's important to finish the full course. For both the oral suspension and the tablets, the guidance is to continue for at least 48 hours after symptoms disappear. Stopping too soon can allow the yeast to bounce back, and then you'd need to start all over.
    Is nystatin safe for babies and young children? ▾
    Yes — the oral suspension and topical forms are used in infants and children, including newborns. For infants getting the suspension, there's specific dosing guidance, and a dropper is used to place the medicine in each side of the mouth. Always follow the exact instructions your prescriber gave you for your child's age and weight, rather than guessing.
    Can I use the topical cream or powder anywhere on my body? ▾
    The topical nystatin forms are for skin and mucous membrane use only. They should never go in your eyes and are not meant to be taken by mouth or used vaginally — those uses are not approved. Stick to the area your prescriber told you to treat, and if you're unsure whether a particular spot is appropriate, just ask your pharmacist or doctor before applying it.
    Is Nystatin available over the counter? ▾
    Nystatin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
    When was Nystatin first available? ▾
    Nystatin has been available in the United States since at least 1964, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Nystatin? ▾
    Nystatin is supplied by 71 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, NuCare Pharmaceuticals,Inc..

    💬 Answers drafted from Nystatin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

    🧰 Keep exploring

    📊Nystatin supplement interactions20 checked — ranked by severity 🌿Drug & Supplement CheckerNystatin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Nystatin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

    💊 How Nystatin comes

    Nystatin is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

    Topical cream, ointment or gel

    By mouth · On the skin
    Brands Mycostatin
    How this form is used
    What it may be used for
    • Mycostatin cream treats cutaneous or mucocutaneous Candida infections of the skin
    • Nystatin Cream treats cutaneous or mucocutaneous mycotic infections caused by Candida species
    • Nystatin ointment treats cutaneous or mucocutaneous mycotic infections caused by Candida species
    Important instructions
    • Mycostatin: apply liberally to affected areas twice daily or as directed until healing is complete
    • Nystatin Cream: apply liberally to affected areas twice daily or as indicated until healing is complete
    • Nystatin ointment: apply liberally to affected areas twice daily or as indicated until healing is complete
    • Very moist lesions may be better treated with nystatin topical powder; nystatin cream is generally preferred over ointment for skin fold (intertriginous) areas
    Available strengths 4 strengths
    100000 U/g 100000 [USP'U]/g NYSTATIN 100000 1/g NYSTATIN 100000 U/g
    109 FDA-listed product records ⓘ

    Oral suspension

    By mouth
    How this form is used
    What it may be used for
    • Nystatin Oral Suspension treats candidiasis (yeast infection) in the oral cavity
    • Nystatin oral suspension treats infections of the oral cavity caused by Candida albicans
    Important instructions
    • Swish the suspension in the mouth as long as possible before swallowing
    • For infants and young children, use the dropper to place half the dose in each side of the mouth; avoid feeding for 5 to 10 minutes after
    • Adults and children take doses four times daily
    • Continue treatment for at least 48 hours after symptoms disappear and the infection is confirmed cleared
    Available strengths 3 strengths
    100000 [USP'U]/mL NYSTATIN 100000 U/mL 500000 [USP'U]/5 mL
    67 FDA-listed product records ⓘ

    Topical powder

    On the skin
    Brands Klayesta Nyamyc Nystatin Topical Powder Nystop
    How this form is used
    What it may be used for
    • Klayesta treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species
    • Nyamyc treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species
    • Nystop treats cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species
    • Topical powders are especially useful for very moist Candida lesions
    Important instructions
    • Apply to Candida lesions two or three times daily until healing is complete
    • For Candida foot infections, dust the powder on the feet and inside all footwear
    • Klayesta, Nyamyc, and Nystatin Topical Powder are not for systemic, oral, intravaginal, or eye use
    • Suitable for adults and pediatric patients including neonates
    Available strengths 4 strengths
    100000 1/g 100000 U/g 100000 [USP'U]/g NYSTATIN 100000 U/g
    43 FDA-listed product records ⓘ

    Tablet

    By mouth
    How this form is used
    What it may be used for
    • Nystatin tablets are indicated for non-esophageal mucous membrane gastrointestinal candidiasis
    Important instructions
    • Take nystatin tablets three times daily
    • Continue treatment for at least 48 hours after clinical cure to prevent relapse
    Available strengths 1 strength
    500000 [USP'U]
    20 FDA-listed product records ⓘ

    Oral solution

    By mouth
    Available strengths 1 strength
    100000 [USP'U]/mL
    3 FDA-listed product records ⓘ

    📊 Nystatin across the U.S. market

    How Nystatin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

    5
    Dose forms ⓘ
    71
    Manufacturers
    8
    Brand names
    252
    FDA-listed product records ⓘ
    1964
    First marketed ⓘ

    FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

    Bryant Ranch Prepack20%
    A-S Medication Solutions10%
    NuCare Pharmaceuticals,Inc.9%
    Preferred Pharmaceuticals Inc.5%
    Proficient Rx LP4%
    Padagis Israel Pharmaceuticals Ltd3%
    Other makers50%

    Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    📈 How widely Nystatin is used

    A general measure of how commonly Nystatin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

    Think of this as a proxy for how widely Nystatin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

    2,190,507
    Medicaid prescriptions filled (Q1–Q4 2025)
    $33.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Nystatin prescribed? Of the 1,596 medications we measure, Nystatin ranks #102 by Medicaid prescriptions — more than 94% of them.

    Where Nystatin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #102 of 1,596
    #97 Methocarbamol 2,261,221 Rx #98 Tizanidine 2,254,693 Rx #99 Cefdinir 2,236,722 Rx #100 Sulfamethoxazole / Tri... 2,217,156 Rx #101 Carvedilol 2,202,041 Rx #102 Nystatin 2,190,507 Rx #103 Benzonatate 2,171,868 Rx #104 Apixaban 2,151,899 Rx #105 Lidocaine Transdermal... 2,146,915 Rx #106 Baclofen 2,144,009 Rx #107 Tamsulosin 2,108,678 Rx

    Utilization by Nystatin product

    Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

    The 100000 units/mL topical cream is the most-dispensed Nystatin product — about 36% of these Medicaid prescriptions.

    nystatin 100000 UNT/ML Topical Cream Most dispensed

    793,854 Medicaid prescriptions (Q1–Q4 2025) 36% of Nystatin prescriptions shown $9.9M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

    Summed across the 10 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 543546

    nystatin 100 UNT/MG Topical Powder

    498,021 Medicaid prescriptions (Q1–Q4 2025) 23% of Nystatin prescriptions shown $9.8M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

    Summed across the 20 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 646456

    nystatin 100000 UNT/ML Oral Suspension

    472,557 Medicaid prescriptions (Q1–Q4 2025) 22% of Nystatin prescriptions shown $7.5M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

    Summed across the 9 of 101 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312055

    nystatin 100 UNT/MG Topical Ointment

    419,082 Medicaid prescriptions (Q1–Q4 2025) 19% of Nystatin prescriptions shown $5.8M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

    Summed across the 12 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 884308

    nystatin 500000 UNT Oral Tablet

    6,993 Medicaid prescriptions (Q1–Q4 2025) <1% of Nystatin prescriptions shown $260,834 gross reimbursement (before rebates) ≈ $37 per prescription (gross)

    Summed across the 2 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312059

    Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

    Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Nystatin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 53 of 265 listed Nystatin NDCs with Medicaid activity.

    🔍 Compare Nystatin products

    A representative set of FDA-listed product records for Nystatin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

    Showing 200 of 252 products — FDA National Drug Code Directory. See every product, package size and price: browse all 252 Nystatin NDCs →

    RxNorm Concept Web — From Ingredient to Every Form and Strength

    This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

    Ingredient (IN) Nystatin RxCUI 7597 9 dose forms · 11 strengths
    1. Dose form (SCDF) Oral Capsule RxCUI 373132 No current FDA listing
      Clinical drug / strength (SCD) 500000 UNT RxCUI 312058 1000000 UNT RxCUI 239241
    2. Dose form (SCDF) Oral Lozenge RxCUI 373134 No current FDA listing
      Clinical drug / strength (SCD) 100000 UNT RxCUI 724575 200000 UNT RxCUI 312056
    3. Dose form (SCDF) Oral Suspension RxCUI 373136 In current FDA listings
      Clinical drug / strength (SCD) 100000 UNT/ML RxCUI 312055
    4. Dose form (SCDF) Oral Tablet RxCUI 373137 In current FDA listings
      Clinical drug / strength (SCD) 500000 UNT RxCUI 312059
    5. Dose form (SCDF) Topical Cream RxCUI 373133 In current FDA listings
      Clinical drug / strength (SCD) 100000 UNT/ML RxCUI 543546
    6. Dose form (SCDF) Topical Lotion RxCUI 378271 In current FDA listings
    7. Dose form (SCDF) Topical Ointment RxCUI 373135 In current FDA listings
      Clinical drug / strength (SCD) 0.1 UNT/MG RxCUI 392197 100 UNT/MG RxCUI 884308
    8. Dose form (SCDF) Topical Powder RxCUI 244416 In current FDA listings
      Clinical drug / strength (SCD) 100 UNT/MG RxCUI 646456
    9. Dose form (SCDF) Vaginal Insert RxCUI 2109014 No current FDA listing
      Clinical drug / strength (SCD) 100000 UNT RxCUI 724568

    Look up RxCUI 7597 in the RxCUI Atlas →

    RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

    🏷️ Sold under these brand names

    Mycostatin Oral Tablets Nilstat Oral Tablets Nilstat Suspension Nystex Suspension Bio-Statin Nystop Nyamyc Klayesta Mycostatin Nystatin Topical Powder

    🏭 Manufacturers & labelers

    Bryant Ranch Prepack 43 A-S Medication Solutions 21 NuCare Pharmaceuticals,Inc. 19 Preferred Pharmaceuticals Inc. 11 Proficient Rx LP 9 Padagis Israel Pharmaceuticals Ltd 6 Preferred Pharmaceuticals, Inc. 6 Cardinal Health 107, LLC 6 Torrent Pharmaceuticals Limited 6 Leading Pharma, LLC 5 RPK Pharmaceuticals, Inc. 5 Epic Pharma, LLC 4 Zydus Lifesciences Limited 4 Taro Pharmaceuticals U.S.A., Inc. 4 Padagis US LLC 4 Atlantic Biologicals Corp. 4 Teva Pharmaceuticals USA, Inc. 4 AvKARE 3 Pharmaceutical Associates, Inc. 3 Crown Laboratories 3 Upsher-Smith Laboratories, LLC 3 Actavis Pharma, Inc. 3 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3 Cardinal Health 3

    …and 16 more on the FDA NDC directory.

    RxNorm drug class

    Nystatin belongs to the Polyene Antifungal class.

    Pharmacologic class Polyene Antifungal
    Drug family (ATC) Antibiotics, Antibiotics, Antibiotics

    Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

    🔬 Where this comes from

    Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

    📄
    FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 9, 2025
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nystatin.
    📈
    Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
    🚨
    Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
    🧾 Clinical label set — FDA-filed SPL labels retained for Nystatin after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    70
    NDC products indexed
    252
    Distinct labelers/manufacturers represented
    71
    Linked representative label ⓘ
    Upsher-Smith Laboratories, LLC
    Linked label effective
    Jul 9, 2025
    Composite sections available
    15
    Linked SPL Set ID
    01b44f91-9b68-464a-9693-b5d3e793bf3c
    Linked SPL Document ID
    3984f88f-d61f-1fa9-e063-6394a90acb11
    Open the linked representative label on DailyMed ↗

    How we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 70 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

    For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Upsher-Smith Laboratories, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

    This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.