Prescription and over-the-counter medicine
Neomycin First approved as Mycifradin
Neomycin (Mycifradin) is a prescription and over-the-counter medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.833 per neomycin 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the neomycin FDA label on DailyMed (effective February 12, 2026); the NDA 50285 record on Drugs@FDA; every neomycin label on DailyMed.
Highlights of the record
FDA label of February 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SYSTEMIC ABSORPTION OF NEOMYCIN OCCURS FOLLOWING ORAL ADMINISTRATION AND TOXIC REACTIONS MAY OCCUR..
Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use. NEUROTOXICITY (INCLUDING OTOTOXICITY) AND NEPHROTOXICITY FOLLOWING THE ORAL USE OF NEOMYCIN SULFATE HAVE BEEN REPORTED, EVEN WHEN USED IN RECOMMENDED DOSES. THE POTENTIAL FOR NEPHROTOXICITY, PERMANENT BILATERAL AUDITORY OTOTOXICITY AND SOMETIMES VESTIBULAR TOXICITY IS PRESENT IN PATIENTS WITH NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/OR FOR LONGER PERIODS THAN RECOMMENDED. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). THE RISK OF NEPHROTOXICITY AND OTOTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued. Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. […]
This box is printed on the prescription label of neomycin; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usage(s) ■ First aid to help prevent infection in minor cuts, scrapes, and burns
Forms and strengths
- 500 mg
Tablet.
On the market
- Earliest approval on file
- March 13, 2009 Mycifradin, Pharmacia And Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first September 2, 1964; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included; 10 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.833 per tablet Neomycin 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest August 23, 2022; 2 more by firms not listed as its makers
- FAERS reports
- 2,716 through July 30, 2026
What is neomycin used for?
From the label: indications and usage(s) ■ First aid to help prevent infection in minor cuts, scrapes, and burns
FDA pharmacologic class: Aminoglycoside Antibacterial.
Source: FDA drug label (Neomycin Sulfate), Aldermed Inc., effective February 12, 2026 (SPL set 4978bb06-8b7c-9a44-e063-6294a90ac4cf), via openFDA; the full label on DailyMed
Is there a generic for neomycin (Mycifradin)?
The FDA approved the first generic neomycin on September 2, 1964. 7 generic applications are approved; 2 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 from 4 labelers 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.
- 2009 earliest approval on file
- 1964 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for neomycin (Mycifradin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.833 per Neomycin 500 mg tablet, down 5% from $0.877 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Neomycin 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Neomycin 500 mg tablet | Generic | $0.833 per tablet | $24.99 | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has neomycin been recalled?
The FDA's Enforcement Report lists 8 recalls naming neomycin since 2013: 0 Class I (the most serious), 8 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of neomycin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 23, 2022 | Class II | Teva Pharmaceuticals USA Inc | CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate … |
| March 19, 2021 | Class II | X-Gen Pharmaceuticals Inc. | Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| July 18, 2019 | Class II | Preferred Pharmaceuticals, Inc | CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. |
| July 12, 2019 | Class II | H J Harkins Company Inc dba Pharma Pac | CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. |
| April 2, 2019 | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderson … not a listed maker | Lack of sterility assurance. |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; NEOMYCIN SULFATE, Tablet, 500 mg may be potentially mislabeled as IMIPRAMINE HCL, Tablet, 25 mg, NDC 00781176401, Pedigree: AD49448_10 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the neomycin label say about other medicines?
The neomycin label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name neomycin. 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 |
|---|---|---|
| Amphotericin b | boxed warning (prescription label) | Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. |
| Bacitracin | boxed warning (prescription label) | Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. |
| Cisplatin | boxed warning (prescription label) | Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. |
| Ethacrynic acid | boxed warning (prescription label) | The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. |
| Furosemide | boxed warning (prescription label) | The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. |
| Paromomycin | boxed warning (prescription label) | Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. |
| Polymyxin b | boxed warning (prescription label) | Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. |
| Succinylcholine | boxed warning (prescription label) | The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of … |
| Vancomycin | boxed warning (prescription label) | Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. |
Other labels that name neomycin
Source: FDA drug label (Neomycin Sulfate), Aldermed Inc., effective February 12, 2026 (SPL set 4978bb06-8b7c-9a44-e063-6294a90ac4cf), via openFDA; the full label on DailyMed
What do FAERS reports show for neomycin?
The FDA Adverse Event Reporting System holds 2,716 reports that list neomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 319 are coded as a death and 764 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.
Reports received each year
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 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other