Prescription medicine
Neomycin and polymyxin b First approved as Statrol
Neomycin and polymyxin b (Statrol) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the neomycin and polymyxin b FDA label on DailyMed (effective March 18, 2026, XGen Pharmaceuticals DJB, Inc.); the NDA 50344 record on Drugs@FDA; every neomycin and polymyxin b label on DailyMed.
Highlights of the record
FDA label of March 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNeomycin 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.
Forms and strengths
- 40 mg/ml
Solution.
On the market
- Earliest approval on file
- March 12, 1974 Statrol, Alcon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first June 28, 1966; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5 through July 30, 2026
What is neomycin and polymyxin b used for?
From the label: indications and usageNeomycin 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. Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. […]
FDA pharmacologic class: Aminoglycoside Antibacterial and Polymyxin-class Antibacterial.
Source: FDA drug label (Neomycin and Polymyxin B Sulfates), XGen Pharmaceuticals DJB, Inc., effective March 18, 2026 (SPL set a2f47d77-efd3-4c84-a364-08fb6d9978eb), via openFDA; the full label on DailyMed
Is there a generic for neomycin and polymyxin b (Statrol)?
The FDA approved the first generic neomycin and polymyxin b on June 28, 1966. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists neomycin and polymyxin b from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1974 earliest approval on file
- 1966 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the neomycin and polymyxin b label say about other medicines?
The neomycin and polymyxin b label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Streptomycin | warnings | Aminoglycoside antibiotics cross the placenta and there have been several reports of total, irreversible, bilateral, congenital deafness in children whose mothers received streptomycin during pregnancy. |
Source: FDA drug label (Neomycin and Polymyxin B Sulfates), XGen Pharmaceuticals DJB, Inc., effective March 18, 2026 (SPL set a2f47d77-efd3-4c84-a364-08fb6d9978eb), via openFDA; the full label on DailyMed
What do FAERS reports show for neomycin and polymyxin b?
The FDA Adverse Event Reporting System holds 5 reports that list neomycin and polymyxin b among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other aminoglycoside antibacterials
- the pharmacologic class, with prices and generics
- Neomycin and polymyxin b side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other