Quick answers
- What is Neomycin sulfate, polymyxin b sulfate and hydrocortisone used for?
- The FDA-approved label (Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Preferred Pharmaceuticals, Inc., August 4, 2026) says: “For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Neomycin sulfate, polymyxin b sulfate and hydrocortisone have a boxed warning?
- The label we quote has no boxed warning, but 3 of 25 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Neomycin sulfate, polymyxin b sulfate and hydrocortisone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Neomycin sulfate, polymyxin b sulfate and hydrocortisone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Neomycin sulfate, polymyxin b sulfate and hydrocortisone?
- 15 companies list prescription products of Neomycin sulfate, polymyxin b sulfate and hydrocortisone in the FDA NDC Directory, including Proficient Rx LP, A-S Medication Solutions and Preferred Pharmaceuticals Inc..
What Neomycin sulfate, polymyxin b sulfate and hydrocortisone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
— FDA label: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Preferred Pharmaceuticals, Inc., effective August 4, 2026. Read the full label on DailyMed →
The FDA has 25 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.
3 of 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · Suspension · Suspension/ drops · Solution |
|---|---|
| Route | Auricular (otic) · Ophthalmic |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Neomycin and Polymyxin B Sulfates and Hydrocortisone, Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic |
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 |
|---|---|---|
| hydrocortisone 10 mg/mL · neomycin sulfate 3.5 mg/mL · polymyxin b sulfate 10000 USP units/mL solution/ drops | Generic | $5.13 per mL |
| hydrocortisone 10 mg/mL · neomycin sulfate 3.5 mg/mL · polymyxin b sulfate 10000 USP units/mL suspension | Generic | $3.84–$17.54 per mL 3 packages, lowest to highest |
| hydrocortisone 10 mg/mL · neomycin sulfate 3.5 mg/mL · polymyxin b sulfate 10000 USP units/mL suspension/ drops | Generic | $3.84 per mL |
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.
- Proficient Rx LP4 products
- A-S Medication Solutions4 products
- Preferred Pharmaceuticals Inc.3 products
- Sandoz Inc3 products
- Amneal Pharmaceuticals NY LLC2 products
- NuCare Pharmaceuticals, Inc.2 products
- Orbicular Pharmaceutical Technologies Private Limited1 product
- Sportpharm LLC1 product
- Bausch & Lomb Incorporated1 product
- Asclemed USA, Inc.1 product
- Bryant Ranch Prepack1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Bausch & Lomb Incoporated1 product
- Remedyrepack Inc.1 product
- Rising Pharma Holdings, 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 |
|---|---|---|---|
| NDA060613 CASPORYN HC | Casper Pharma LLC | May 25, 1975 | 8, latest March 15, 2019 2019: Manufacturing (CMC) · 2017: Labeling · 2000: Labeling |
Generic approvals (8)
- ANDA062423Sandoz · August 25, 1983
- ANDA062488Sandoz · November 6, 1985
- ANDA062874Sandoz · May 11, 1988
- ANDA064053Bausch and Lomb Inc · December 29, 1995
- ANDA064065Bausch and Lomb Inc · August 28, 1996
- ANDA217735Amneal · September 30, 2025
- ANDA217803Amneal · October 29, 2025
- ANDA220938Orbicular Pharm Tech · August 27, 2026
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) | 204423, 204874, 310687 |
|---|---|
| SPL set ID of the quoted label | 5f17fae0-c6ea-452e-b84f-066caf2a95fc |
| FDA labels (SPL) | 25 |
| FDA applications | NDA060613, 8 ANDA |
| Active ingredients (FDA) | HYDROCORTISONE / NEOMYCIN / POLYMYXIN B |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Preferred Pharmaceuticals, Inc., effective August 4, 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 →