Quick answers
- What is Neomycin and polymyxin b sulfates used for?
- The FDA-approved label (Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., March 18, 2026) says: “Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Neomycin and polymyxin b sulfates?
- The “Adverse Reactions” section of the FDA label (Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., March 18, 2026) begins: “Neomycin occasionally causes skin sensitization when applied topically; however, topical application to mucus membranes rarely results in local or systemic hypersensitivity reactions. Irritation of the urinary bladder mucosa has been reported. Signs of ototoxicity and nephrotoxicity have been reported following parenteral use of drugs and following the oral and topical use of neomycin (see WARNINGS).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Neomycin and polymyxin b sulfates have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Neomycin and polymyxin b sulfates?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Neomycin and polymyxin b sulfates been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Neomycin and polymyxin b sulfates?
- 1 company lists prescription products of Neomycin and polymyxin b sulfates in the FDA NDC Directory, including XGen Pharmaceuticals DJB, Inc.
What Neomycin and polymyxin b sulfates is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. …
— FDA label: Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., effective March 18, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution, irrigation), Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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.
Neomycin and polymyxin b sulfates side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Neomycin occasionally causes skin sensitization when applied topically; however, topical application to mucus membranes rarely results in local or systemic hypersensitivity reactions. Irritation of the urinary bladder mucosa has been reported. Signs of ototoxicity and nephrotoxicity have been reported following parenteral use of drugs and following the oral and topical use of neomycin (see WARNINGS).
Read more of this section
To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., effective March 18, 2026. Read the full label on DailyMed →
Neomycin and polymyxin b sulfates dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
This preparation is specifically designed for use with “three-way catheters or with other catheter systems permitting continuous irrigation of the urinary bladder. The usual irrigation dose is 1 mL of Neomycin and Polymyxin B Sulfates Solution for Irrigation a day for up to 10 days. Using strict aseptic techniques, 1 mL of Neomycin and Polymyxin B Sulfates Solution for Irrigation should be added to a 1,000-mL container of isotonic saline solution.
Read more of this section
This container should then be connected to the inflow lumen of the “three-way” catheter which has been inserted with full aseptic precautions; use of a sterile lubricant is recommended during insertion of the catheter. The outflow lumen should be connected, via a sterile disposable plastic tube, to a disposable plastic collection bag. Stringent procedures, such as taping the inflow and outflow junction at the catheter, should be observed when necessary to insure the junctional integrity of the system. For most patients, the inflow rate of the 1,000-mL saline solution of neomycin and polymyxin B should be adjusted to a slow drip to deliver about 1,000 mL every 24 hours. If the patient’s urine output exceeds 2 liters per day, it is recommended that the inflow rate be adjusted to deliver 2,000 mL of the solution in a 24-hour period. It is important that the rinse of the bladder be continuous; the inflow or rinse solution should not be interrupted for more than a few minutes. Preparation of the irrigation solution should be performed with strict aseptic techniques. The prepared solution should be stored at 4°C, and should be used within 48 hours following preparation to reduce the risk of contamination with resistant microorganisms.
— FDA label: Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., effective March 18, 2026. Read the full label on DailyMed →
Neomycin and polymyxin b sulfates in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Teratogenic Effects Pregnancy Category D. See WARNINGS section.
— FDA label: Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., effective March 18, 2026. Read the full label on DailyMed →
When Neomycin and polymyxin b sulfates should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Hypersensitivity to neomycin, the polymyxins, or any ingredient in the solution is a contraindication to its use. A history of hypersensitivity or serious toxic reaction to an aminoglycoside may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs of this class.
— FDA label: Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., effective March 18, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Irrigation |
| Prescription products | 2 in the FDA NDC Directory |
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.
- XGen Pharmaceuticals DJB, Inc.2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA065106Xgen Pharms · January 31, 2006
- ANDA065108Xgen Pharms · January 31, 2006
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 314124 |
|---|---|
| SPL set ID of the quoted label | a2f47d77-efd3-4c84-a364-08fb6d9978eb |
| FDA labels (SPL) | 1 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | NEOMYCIN / POLYMYXIN B |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- SepsisCondition named on the label: hospitals that treat it
- XGen Pharmaceuticals DJB, Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Neomycin and Polymyxin B Sulfates, XGen Pharmaceuticals DJB, Inc., effective March 18, 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 →