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Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL Solution/ Drops — NDC 63187-0631-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL Solution/ Drops — NDC 63187-631-10 (Billing 63187-0631-10)

by Proficient Rx LP · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL Solution/ Drops from Proficient Rx LP, marketed since Feb 1997 and currently FDA-listed. It is this product's only package size.

NDC 63187-0631-10
🏷️ FDA NDC (as labeled) 63187-631-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63187-631-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63187 labeler · 631 product · 10 package
Package marketed since
Dec 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0363187631109
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-631-10
Product NDC 63187-631
11-digit billing NDC 63187063110
NCPDP billing unit ML — per mL (volume)
RxCUI 244967
UNII 19371312D4, E377MF8EQ8
UPC 0363187631109
Application # ANDA064120
SPL Set ID d1f55327-156f-44cd-b0fc-b1a938e8aa73
Established class (EPC) Dihydrofolate Reductase Inhibitor Antibacterial; Polymyxin-class Antibacterial
Mechanism of action Cytochrome P450 2C8 Inhibitors; Dihydrofolate Reductase Inhibitors; Organic Cation Transporter 2 Inhibitors
Chemical class Polymyxins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1997-02-14
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 048570
GCN 14294
HICL code 004710
Ingredient (HICL) Polymyxin B Sulf/Trimethoprim
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 08:12.28.28
AHFS class Polymyxin Antibiotics
FDB label name POLYMYXIN B-TMP EYE DROPS
FDB brand name Polymyxin B Sul-Trimethoprim
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048570
  • GCN: 14294
  • HICL (First Databank): 004710
  • AHFS class code: 08:12.28.28
  • RxCUI (RxNorm): 244967
Why two NDCs? The FDA registers this code as 63187-631-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0631-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Dihydrofolate Reductase Inhibitor Antibacterial class.

Pharmacologic class Dihydrofolate Reductase Inhibitor Antibacterial
Drug family (ATC) Trimethoprim and derivatives
How it works Dihydrofolate Reductase Inhibitors, Organic Cation Transporter 2 Inhibitors, Cytochrome P450 2C8 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name POLYMYXIN B-TMP EYE DROPS Ingredient Polymyxin B Sulf/Trimethoprim

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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 · Q2 2026 $0.8331 $8.33 / 10 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0631-10 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 2018-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 24208-0315-10 Bausch 1 bottle $0.452 AT Availability likely —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 61314-0628-10 Sandoz 10 ml $0.452 AT Availability likely —
polymyxin b sulfate and trimethoprim sulfate 10000 [iU]/mL; 1 mg/mL 70069-0311-01 Somerset 1 bottle $0.452 AT Availability likely —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 50090-2925-00 A-S 10 ml — AT FDA listed —
Trimethoprim sulfate and Polymyxin B sulfate 1 mg/mL; 10000 [USP'U]/mL 63187-0193-10 Proficient 1 bottle — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mLthis 63187-0631-10 Proficient 1 bottle — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 63187-0834-10 Proficient 10 ml — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 68071-1651-05 NuCare 10 ml — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 1 mg/mL; 10000 [USP'U]/mL 68071-4103-05 NuCare 10 ml — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 68788-6927-01 Preferred 10 ml — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 68788-8152-01 Preferred 1 bottle — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 70518-1735-00 REMEDYREPACK 10 ml — AT FDA listed —
polymyxin b sulfate and trimethoprim sulfate 10000 [iU]/mL; 1 mg/mL 70518-4381-00 REMEDYREPACK 1 bottle — AT FDA listed —
Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL; 1 mg/mL 85766-0141-10 Sportpharm 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1997
On the market since
Feb 1997
📍
2026
Currently FDA-listed
29 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064120 (ANDA)
Labeler code63187
First marketedFeb 1997
Product typeHuman Prescription Drug
Portfolio1,729 products on file

More NDCs from Proficient Rx LP labeler code 63187

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

INDICATIONS AND USAGE Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis,Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonasaeruginosa .** **Efficacy for this organism in this organ system was studied in fewer than 10 infections.

⏱️ Dosage and Administration 32 words ▾

DOSAGE AND ADMINISTRATION In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Polymyxin B sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

⚠️ Warnings 40 words ▾

WARNINGS NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to polymyxin B sulfate and trimethoprim ophthalmic solution occurs, discontinue use. Polymyxin B sulfate and trimethoprim ophthalmic solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.

🤒 Adverse Reactions 69 words ▾

ADVERSE REACTIONS The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash.

Photosensitivity has been reported in patients taking oral trimethoprim.

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with polymyxin B sulfate. It is not known whether polymyxin B sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Trimethoprim has been shown to be teratogenic in the rat when given in oral doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with oral doses 6 times the human therapeutic dose. While there are no large well-controlled studies on the use of trimethoprim in pregnant women, Brumfitt and Pursell, in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or oral trimethoprim in combination with sulfamethoxazole.

The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral trimethoprim and sulfamethoxazole at the time of conception or shortly thereafter.

Because trimethoprim may interfere with folic acid metabolism, trimethoprim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.

🧒 Pediatric Use 21 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 months have not been established (see WARNINGS ).

🧓 Geriatric Use 18 words ▾

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Trimethoprim is a synthetic antibacterial drug active against a wide variety of aerobic gram-positive and gram-negative ophthalmic pathogens. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase. This binding is stronger for the bacterial enzyme than for the corresponding mammalian enzyme and therefore selectively interferes with bacterial biosynthesis of nucleic acids and proteins.

Polymyxin B, a cyclic lipopeptide antibiotic, is bactericidal for a variety of gram-negative organisms, especially Pseudomonas aeruginosa . It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane. Blood samples were obtained from 11 human volunteers at 20 minutes, 1 hour and 3 hours following instillation in the eye of 2 drops of ophthalmic solution containing 1 mg trimethoprim and 10,000 units polymyxin B per mL.

Peak serum concentrations were approximately 0.03 μg/mL trimethoprim and 1 unit/mL polymyxin B. Microbiology : In vitro studies have demonstrated that the anti-infective components of trimethoprim sulfate and polymyxin B sulfate ophthalmic solution are active against the following bacterial pathogens that are capable of causing external infections of the eye: Trimethoprim: Staphylococcus aureus and Staphylococcus epidermidis, Streptococcus pyogenes,Streptococcus faecalis, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus aegyptius,Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis (indole-negative), Proteus vulgaris (indolepositive), Enterobacter aerogenes , and Serratia marcescens .

Polymyxin B: Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes and Haemophilus influenzae .

📦 How Supplied / Storage and Handling 101 words ▾

HOW SUPPLIED Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip in the following size: 10 mL - NDC 63187-631-10 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance.

RETAIN IN CARTON UNTIL TIME OF USE. Revised: November 2012 Bausch & Lomb Incorporated Tampa, Florida 33637 ©Bausch & Lomb Incorporated 9117801 (Folded) 9117901 (Flat) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

📋 Description 181 words ▾

DESCRIPTION Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution USP* is a sterile antimicrobial solution for topical ophthalmic use. It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Trimethoprim sulfate, a white, odorless, crystalline powder, is represented by the following structural formula: C 28 H 38 N 8 O 10 S Mol.

Wt. 678.72 Chemical Name: Trimethoprim sulfate, 2,4-diamino-5-(3,4 5-trimethoxybenzyl)pyrimidine sulfate (2:1) Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (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 formula is: Each mL Contains: ACTIVES: Polymyxin B Sulfate equal to 10,000 polymyxin B units, Trimethoprim Sulfate (equivalent to trimethoprim 1 mg); INACTIVES: Purified Water, Sodium Chloride. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 6.2).

PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%. Trimethoprim sulfate (Structural formula) Polymyxin B Sulfate, the sulfate salt of polymyxin Bl and B2 (Structural formula)

💬 Information for Patients 66 words ▾

Information for patients Avoid contaminating the applicator tip with material from the eye, fingers, or other source. This precaution is necessary if the sterility of the drops is to be maintained. If redness, irritation, swelling or pain persists or increases, discontinue use immediately and contact your physician. Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Information for patients Avoid contaminating the applicator tip with material from the eye, fingers, or other source.

This precaution is necessary if the sterility of the drops is to be maintained. If redness, irritation, swelling or pain persists or increases, discontinue use immediately and contact your physician. Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections.

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Long-term studies in animals to evaluate carcinogenic potential have not been conducted with polymyxin B sulfate or trimethoprim. Mutagenesis: Trimethoprim was demonstrated to be non-mutagenic in the Ames assay. In studies at two laboratories no chromosomal damage was detected in cultured Chinese hamster ovary cells at concentrations approximately 500 times human plasma levels after oral administration; at concentrations approximately 1000 times human plasma levels after oral administration in these same cells, a low level of chromosomal damage was induced at one of the laboratories.

Studies to evaluate mutagenic potential have not been conducted with polymyxin B sulfate. Impairment of Fertility: Polymyxin B sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on fertility or general reproductive performance were observed in rats given trimethoprim in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.

Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with polymyxin B sulfate. It is not known whether polymyxin B sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Trimethoprim has been shown to be teratogenic in the rat when given in oral doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with oral doses 6 times the human therapeutic dose. While there are no large well-controlled studies on the use of trimethoprim in pregnant women, Brumfitt and Pursell, in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or oral trimethoprim in combination with sulfamethoxazole.

The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral trimethoprim and sulfamethoxazole at the time of conception or shortly thereafter.

Because trimethoprim may interfere with folic acid metabolism, trimethoprim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival. 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 polymyxin B sulfate and trimethoprim ophthalmic solution is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 months have not been established (see WARNINGS ). Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and oth… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 40 words ▾

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 polymyxin B sulfate and trimethoprim ophthalmic solution is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 159 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Long-term studies in animals to evaluate carcinogenic potential have not been conducted with polymyxin B sulfate or trimethoprim. Mutagenesis: Trimethoprim was demonstrated to be non-mutagenic in the Ames assay. In studies at two laboratories no chromosomal damage was detected in cultured Chinese hamster ovary cells at concentrations approximately 500 times human plasma levels after oral administration; at concentrations approximately 1000 times human plasma levels after oral administration in these same cells, a low level of chromosomal damage was induced at one of the laboratories.

Studies to evaluate mutagenic potential have not been conducted with polymyxin B sulfate. Impairment of Fertility: Polymyxin B sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on fertility or general reproductive performance were observed in rats given trimethoprim in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.

📄 Package Label / Principal Display Panel 25 words ▾

Principal Display Panel NDC 63187-631-10 Polymyxin B Sulfate and Trimethoprim Ophthmalic Solution USP (Sterile) [icon-eye] [icon dropper] [icon 10 mL] 10 ml Rx only 63187-631-10

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Polymyxin B Sulfate and Trimethoprim Sulfate — the ingredient across all brands.

Top reported reactions

Eye Pruritus21
Ocular Hyperaemia21
Eye Irritation19
Eye Swelling18
Pain12
Eye Pain11
Eye Discharge10

Reporter sex

0 reports

Serious outcomes

Disabling3
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ 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 ✓ Available
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63187-0628-05 · Proficient 63187-0632-30 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.