![NYSTATIN 100000 [USP'U]/g Ointment — NDC 69315-0307-30 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8900ba02-2c6a-4dd4-b82f-45620c06e255&name=Carton-100000unit15gm.jpg)
NYSTATIN 100000 [USP'U]/g Ointment
Other active recalls for Nystatin (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Polyene Antifungal class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nystatin — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
-
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.278 | $8.33 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.4011 | $12.03 / 30 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nystatin 100000 [USP'U]/g 45802-0059-11 | Padagis | 1 tube | $0.156 | AT | Availability likely | save 44% |
| Nystatin 100000 [USP'U]/g 51672-1289-01 | Sun | 1 tube | $0.200 | AT | Availability likely | save 28% |
| Nystatin 100000 [USP'U]/g 59651-0907-14 | Aurobindo | 1 tube | $0.200 | AT | Availability likely | save 28% |
| Nystatin 100000 [USP'U]/g 00472-0166-15 | Actavis | 1 tube | $0.229 | AT | Availability likely | save 17% |
| Nystatin 100000 [USP'U]/g 00713-0686-15 | Cosette | 1 tube | $0.229 | AT | Availability likely | save 17% |
| Nystatin 100000 U/g 13668-0534-01 | Torrent | 15 g | $0.229 | AT | Availability likely | save 17% |
| Nystatin 100000 1/g 33342-0481-15 | Macleods | 1 tube | $0.229 | AT | Availability likely | save 17% |
| Nystatin 100000 U/g 72578-0089-01 | Viona | 15 g | $0.229 | AT | Availability likely | save 17% |
| Nystatin 100000 [USP'U]/g 45802-0048-11 | Padagis | 1 tube | $0.243 | AT | Availability likely | save 12% |
| Nystatin 100000 [USP'U]/gthis 69315-0307-30 | Leading | 1 tube | $0.278 | AT | FDA listed | — |
| Nystatin 100000 U/g 50090-5845-00 | A-S | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63187-0464-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 63629-2515-01 | Bryant | 30 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 63629-2516-01 | Bryant | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 70771-1357-01 | Zydus | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 71205-0437-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 72162-2007-02 | Bryant | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-2333-02 | Bryant | 1 tube | — | 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 50090-2854-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-1385-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68071-4293-03 | NuCare | 30 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 71335-2830-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-2496-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Mycostatin 100000 [USP'U]/g 72189-0408-15 | Direct_Rx | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63629-8695-01 | Bryant | 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 63629-8694-01 | 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 [USP'U]/g 68071-2556-05 | NuCare | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-3772-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-3799-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68788-4099-01 | Preferred | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 69315-0307-15 | 1 TUBE in 1 CARTON (69315-307-15) / 15 g in 1 TUBE | $0.3345 / g | $5.02 | 2019-08-19 | Active |
| 69315-0307-30 You're viewing this | 1 TUBE in 1 CARTON (69315-307-30) / 30 g in 1 TUBE | $0.2776 / g | $8.33 | 2019-08-19 | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.2776 NADAC).
Pack size FAQ
What quantity is in NDC 69315-0307-30?
What NDC number is used to bill for this package of NYSTATIN 100000 [USP'U]/g Ointment?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin topical powder 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 Administration ▾
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.
⛔ Contraindications ▾
CONTRAINDICATIONS Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
🤒 Adverse Reactions ▾
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 ). CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.
🤰 Pregnancy ▾
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 Use ▾
Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION ).
🧬 Clinical Pharmacology ▾
CLINCAL 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 ▾
HOW SUPPLIED Nystatin Ointment, USP (100,000 nystatin units per gram) is a yellow ointment available as follows: NDC 69315-307-15 15 gram tube NDC 69315-307-30 30 gram tube STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R0-12/17
📋 Description ▾
DESCRIPTION Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 Nystatin Ointment is for dermatologic use. Nystatin Ointment for topical use contains 100,000 USP nystatin units per gram in a polyethylene and mineral oil base. Chemical-structure
💬 Information for Patients ▾
INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: 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. 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. Laboratory Tests If there is 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 ).