Quick answers
- What is Nystatin used for?
- The FDA-approved label (Nystatin, Chartwell RX, LLC, March 5, 2026) says: “Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nystatin have a boxed warning?
- No. None of the 89 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nystatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nystatin been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started June 23, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nystatin?
- 40 companies list prescription products of Nystatin in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.
What Nystatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
— FDA label: Nystatin, Chartwell RX, LLC, effective March 5, 2026. Read the full label on DailyMed →
The FDA has 89 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 89 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Suspension · Powder · Ointment · Tablet, coated · Tablet, film coated |
|---|---|
| Route | Topical · Oral |
| Prescription products | 93 in the FDA NDC Directory |
| Brand names | Nystop, Klayesta, Nyamyc, Mycostatin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| nystatin 100000 1/g cream | Generic | $0.1408–$0.1888 per gram 2 packages, lowest to highest |
| nystatin 100000 1/g ointment | Generic | $0.2305–$0.2339 per gram 2 packages, lowest to highest |
| nystatin 100000 USP units/g cream | Generic | $0.1408–$0.1888 per gram 8 packages, lowest to highest |
| nystatin 100000 USP units/g ointment | Generic | $0.2305–$0.2339 per gram 6 packages, lowest to highest |
| nystatin 100000 USP units/g powder | Generic | $0.2525–$0.4018 per gram 18 packages, lowest to highest |
| nystatin 100000 USP units/mL suspension | Generic | $0.0554–$0.1430 per mL 5 packages, lowest to highest |
| nystatin 100000 units/g cream | Generic | $0.1408–$0.1888 per gram 2 packages, lowest to highest |
| nystatin 100000 units/g ointment | Generic | $0.2305–$0.2339 per gram 4 packages, lowest to highest |
| nystatin 100000 units/g powder | Generic | $0.2525–$0.4018 per gram 3 packages, lowest to highest |
| nystatin 100000 units/mL suspension | Generic | $0.0554–$0.1430 per mL 3 packages, lowest to highest |
| nystatin 500000 USP units tablet, coated | Generic | $0.4025 per tablet |
| nystatin 500000 USP units tablet, film coated | Generic | $0.4025 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack19 products
- A-S Medication Solutions8 products
- Proficient Rx LP7 products
- NuCare Pharmaceuticals, Inc.7 products
- Preferred Pharmaceuticals Inc.4 products
- Epic Pharma, LLC3 products
- Leading Pharma, LLC3 products
- Zydus Lifesciences Limited2 products
- Kesin Pharma Corporation2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Direct_Rx2 products
- Cosette Pharmaceuticals, Inc.2 products
- Torrent Pharmaceuticals Limited2 products
- Macleods Pharmaceuticals Limited2 products
- Chartwell RX, LLC2 products
- Pharmaceutical Associates, Inc.2 products
- Cardinal Health 107, LLC2 products
- Dr. Reddy's Labratories Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Genus Lifesciences Inc.1 product
- Viona Pharmaceuticals Inc1 product
- Padagis US LLC1 product
- Upsher-Smith Laboratories, LLC1 product
- Kanchan Healthcare Inc1 product
- Atlantic Biologicals Corp.1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Actavis Pharma, Inc.1 product
- AvKARE1 product
- Aurobindo Pharma Limited1 product
- American Health Packaging1 product
- Redpharm Drug1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Crown Laboratories1 product
- Xttrium Laboratories, Inc.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- RedPharm Drug, Inc.1 product
- NorthStar Rx LLC1 product
- Major Pharmaceuticals1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050299 NILSTAT | Chartwell Molecules | April 14, 1971 | 21, latest September 23, 1999 1999: Manufacturing (CMC) · 1998: Manufacturing (CMC) · 1995: Manufacturing (CMC) |
Generic approvals (27)
- ANDA061966Cosette Pharms Nc · May 25, 1976
- ANDA062225Padagis Us · December 11, 1979
- ANDA062474Heritage · December 22, 1983
- ANDA062506Teva · January 16, 1984
- ANDA062472Padagis Us · February 13, 1984
- ANDA062512Pharmobedient · October 29, 1984
- ANDA062840Actavis Mid Atlantic · November 13, 1987
- ANDA062832Sciegen Pharms · December 27, 1991
- ANDA064022Sun Pharma Canada · January 29, 1993
- ANDA064118Padagis Us · August 16, 1996
- ANDA065203DR Reddys Labs SA · July 15, 2004
- ANDA065183Upsher Smith Labs · May 3, 2005
- ANDA065148Genus · June 28, 2005
- ANDA203621Pharm Assoc · January 7, 2016
- ANDA208838Lyne · May 30, 2017
- ANDA208581Zydus Pharms · June 8, 2017
- ANDA207733Crown Labs Inc · September 26, 2017
- ANDA209114Cosette · October 6, 2017
- ANDA210532Epic Pharma LLC · April 30, 2018
- ANDA209082Lyne · May 21, 2018
- ANDA207767Zydus Lifesciences · May 25, 2018
- ANDA211838Torrent · January 28, 2019
- ANDA212557Torrent · July 24, 2019
- ANDA213826Macleods Pharms · January 14, 2021
- ANDA213566Macleods Pharms · August 10, 2021
- ANDA214346Pharmazone · March 10, 2022
- ANDA219527Aurobindo Pharma · March 21, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 23, 2026 · Class II · Ongoing · D-0677-2026
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35 — Padagis US LLC
-
July 29, 2021 · Class II · Terminated · D-0721-2021
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, I — PAI Holdings, LLC. dba Pharmaceutical Associates Inc
-
August 4, 2020 · Class II · Terminated · D-1494-2020
Subpotent drug: Out of specification for assay at the 15-month test interval.
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16 — PAI Holdings, LLC. dba Pharmaceutical Associates Inc
-
June 10, 2020 · Class II · Terminated · D-1339-2020
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15 — Crown Laboratories
-
June 10, 2020 · Class II · Terminated · D-1338-2020
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 — Crown Laboratories
-
March 19, 2020 · Class II · Terminated · D-1060-2020
SubPotent Drug: Low out-of-specification results for assay testing.
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16. — PAI Holdings, LLC. dba Pharmaceutical Associates Inc
-
January 14, 2020 · Class II · Terminated · D-0824-2020
Subpotent: Out of specification for assay at the 12-month time point.
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16 — Pharmaceutical Associates Inc
-
May 29, 2018 · Class III · Terminated · D-0865-2018
Resuspension problems: Out of specification for appearance and resuspendability.
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05 — Pharmaceutical Associates Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nystatin, Chartwell RX, LLC, effective March 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →