Quick answers
- What is Neomycin sulfate, polymyxin b sulfate and dexamethasone used for?
- The FDA-approved label (Maxitrol, Harrow Eye, LLC, October 24, 2025) says: “For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain …” 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 dexamethasone have a boxed warning?
- No. None of the 23 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Neomycin sulfate, polymyxin b sulfate and dexamethasone?
- 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 dexamethasone been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Neomycin sulfate, polymyxin b sulfate and dexamethasone?
- 12 companies list prescription products of Neomycin sulfate, polymyxin b sulfate and dexamethasone in the FDA NDC Directory, including Proficient Rx LP, NuCare Pharmaceuticals, Inc. and A-S Medication Solutions.
What Neomycin sulfate, polymyxin b sulfate and dexamethasone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain …
— FDA label: Maxitrol, Harrow Eye, LLC, effective October 24, 2025. Read the full label on DailyMed →
The FDA has 23 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.
0 of 23 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Ointment · Suspension/ drops · Suspension |
|---|---|
| Route | Ophthalmic · Topical |
| Prescription products | 24 in the FDA NDC Directory |
| Brand names | Neomycin and Polymyxin B Sulfates and Dexamethasone, Neomycin Polymyxin B Sulfates and Dexamethasone, Maxitrol |
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 |
|---|---|---|
| dexamethasone 0.1% · neomycin sulfate 0.35% · polymyxin b sulfate 10000 USP units/g ointment | Generic | $2.46 per gram |
| dexamethasone 0.1% · neomycin sulfate 0.35% · polymyxin b sulfate 10000 units/g ointment | Generic | $2.46 per gram |
| dexamethasone 1 mg/mL · neomycin sulfate 3.5 mg/mL · polymyxin b sulfate 10000 USP units/mL suspension | Generic | $1.85 per mL |
| dexamethasone 1 mg/mL · neomycin sulfate 3.5 mg/mL · polymyxin b sulfate 10000 USP units/mL suspension/ drops | Generic | $1.85 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
- NuCare Pharmaceuticals, Inc.4 products
- A-S Medication Solutions3 products
- Sandoz Inc3 products
- Preferred Pharmaceuticals Inc.2 products
- Bausch & Lomb Incorporated2 products
- Nordic Pharma, Inc.1 product
- DirectRx1 product
- Harrow Eye, LLC1 product
- Novartis Pharmaceuticals Corporation1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Direct_Rx1 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 |
|---|---|---|---|
| NDA050023 MAXITROL | Harrow Eye | June 6, 1963 | 26, latest May 14, 2021 2021: Labeling · 2017: Labeling · 2017: Labeling |
| NDA050065 MAXITROL | Sandoz | July 19, 1963 | 46, latest May 14, 2021 2021: Labeling · 2017: Labeling · 2017: Labeling |
Generic approvals (4)
- ANDA062341Sandoz · May 22, 1984
- ANDA062938Padagis Us · July 31, 1989
- ANDA064063Bausch and Lomb Inc · July 25, 1994
- ANDA064135Bausch and Lomb Inc · September 13, 1995
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1102-2022
cGMP deviations: Temperature abuse
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36 — Mckesson Medical-Surgical Inc. Corporate Office
-
October 17, 2019 · Class III · Terminated · D-0162-2020
Labeling: Incorrect or missing package insert.
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-63 — Sandoz Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 208591, 208601, 309679, 309680 |
|---|---|
| SPL set ID of the quoted label | ecfb954f-5554-0ad2-e053-2995a90a7516 |
| FDA labels (SPL) | 23 |
| FDA applications | NDA050023, NDA050065, 4 ANDA |
| Active ingredients (FDA) | DEXAMETHASONE / NEOMYCIN / POLYMYXIN B |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Maxitrol, Harrow Eye, LLC, effective October 24, 2025; 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 →