Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Neomycin Sulfate, Polymyxin B Sulfate 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Ointment, 1 tube — NDC 13985-607-03 (Billing 13985-0607-03)
This is a package of 1 tube of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Neomycin Sulfate, Polymyxin B Sulfate 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Ointment from MWI, no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 13985-607-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 13985 labeler · 607 product · 03 package
- Barcode (UPC-A, from the NDC)
- 3 1398560703 5
- FDA record last changed
- Jul 14, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- It's a first-aid antibiotic you apply to small, everyday wounds — minor cuts, scrapes, and burns — to help prevent a bacterial infection from developing. Some products also help te...
- What is this triple antibiotic ointment actually for?
- Start by cleaning the wound area. Then apply a small amount — about the size of your fingertip — directly on the area up to 1 to 3 times a day. You can cover it with a sterile band...
- Most people don't have any trouble with it. The most common reaction is a mild skin irritation, redness, itching, or swelling at the spot you applied it. If you use it often, you c...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 7, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 13985-0607-03 You're viewing this Main listing | 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE | 2015-03-23 | — | Inactivated by FDA |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/gthis 13985-0607-03 | MWI | 1 tube | — | — | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Neomycin, Polymyxin, and Bacitracin Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
⛔ Contraindications ▾
CONTRAINDICATIONS: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is contraindicated in individuals who have shown hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS: NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid.
A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication.
Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Adverse reactions have occurred with the anti-infective components of Neomycin and Polymyxin B Sulfate and Bacitracin Zinc Ophthalmic Ointment USP. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS ).
More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin. It is also not known whether Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP should be given to pregnant woman only if dearly needed.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin. Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic, which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.
Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane. Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms.
It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in phospholipid synthesis. Microbiology: Neomycin sulfate, polymyxin B sulfate, and bacitracin zinc together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichiacoli, Haemophilusinfluenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Tube of 1/8 oz. (3.5 g) with ophthalmic tip. NDC13985-607-03 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. apexa ™ Manufactured by: Akorn Inc. Lake Forest IL 60045 Distributed by: MWI Boise, ID 83705 MWNP00N Rev. 10/15
📦 Storage and Handling ▾
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. apexa ™ Manufactured by: Akorn Inc. Lake Forest IL 60045 Distributed by: MWI Boise, ID 83705 MWNP00N Rev. 10/15
📋 Description ▾
DESCRIPTION: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: Neomycin Sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B sulfate equal to 10,000 polymyxin B units, bacitracin zinc equal to 400 bacitracin units, and white petrolatum, q.s. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam.
Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formula are: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus palymyxa (Prazmowski) Migula (Fam.
Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the lichenifoimis group of Bacillus subtilis var Tracy.
It has a potency of not less than 40 bacitracin units per mg. The structural formula is: Neomycin Sulfate Structural Formula Polymyxin B Sulfate Structural Formula Bacitracin Zinc Structural Formula
💬 Information for Patients ▾
Information for Patients: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection. Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General ). If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children.
⚠️ Precautions ▾
PRECAUTIONS: General: As with other antibiotic preparations, prolonged use of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated. Bacterial resistance to Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP may also develop.
If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers, which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients ). Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Information for Patients: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection. Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General ). If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.
Keep tightly closed when not in use. Keep out of reach of children. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin.
Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, liter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.
Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin. It is also not known whether Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP should be given to pregnant woman only if dearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🍼 Nursing Mothers ▾
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.
No adverse effects on male or female fertility, liter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Text for Container Label: NDC 13985-607-03 Neomycin and STERILE Polymyxin B Sulfates, Rx Only and Bacitracin Zinc Ophthalmic Ointment, USP Apexa logo AP 704009 Net Weight: 3.5g (1/8 oz) Principal Display Panel Text for Container Label
Principal Display Panel Text for Carton Label: NDC 13985-607-03 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP STERILE Rx Only Apexa logo AP 704009 Net Weight: 3.5g (1/8 oz) Principal Display Panel Text for Carton Label
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |