{"id":"gramicidin","rwe":[],"_fda":{"id":"2df71383-cdc7-4f27-bf66-4cd1cef9f8a5","set_id":"9691178e-5323-40ce-a8b3-f79e88f02797","openfda":{"unii":["5IE62321P4","057Y626693","19371312D4"],"route":["OPHTHALMIC"],"rxcui":["310594"],"spl_id":["2df71383-cdc7-4f27-bf66-4cd1cef9f8a5"],"brand_name":["NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN"],"spl_set_id":["9691178e-5323-40ce-a8b3-f79e88f02797"],"package_ndc":["50090-0247-0"],"product_ndc":["50090-0247"],"generic_name":["NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["GRAMICIDIN","NEOMYCIN SULFATE","POLYMYXIN B SULFATE"],"manufacturer_name":["A-S Medication Solutions"],"application_number":["ANDA064047"],"original_packager_product_ndc":["24208-790"]},"version":"20","warnings":["WARNINGS NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally. 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. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS : Error! Hyperlink reference not valid. )."],"pregnancy":["Pregnancy: Teratogenic Effects Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B, or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed."],"description":["DESCRIPTION Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is a sterile antimicrobial solution for ophthalmic use. Each mL contains: Actives: neomycin sulfate, (equivalent to 1.75 mg neomycin base), polymyxin B sulfate equal to 10,000 polymyxin B units, gramicidin, 0.025 mg; Inactives: sodium chloride, alcohol (0.5%), Poloxamer 188, propylene glycol, purified water. Hydrochloric acid and/or ammonium hydroxide may be added to adjust pH (4.7-6.0). Preservative: thimerosal 0.001%. 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 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are: 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 milligram, calculated on an anhydrous basis. The structural formulae are: Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are: Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula) Gramicidin (structural formula)"],"precautions":["PRECAUTIONS General As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated. Bacterial resistance to this product 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 : Error! Hyperlink reference not valid. ). If the condition persists or gets worse, or if a rash or other 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 gramicidin. Treatment of cultured 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. Pregnancy: Teratogenic Effects Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B, or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly 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 this product is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"how_supplied":["HOW SUPPLIED Product: 50090-0247 NDC: 50090-0247-0 10 mL in a BOTTLE, DROPPER / 1 in a CARTON"],"microbiology":["Microbiology: Neomycin sulfate, polymyxin B sulfate, and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus , streptococci, including Streptococcus pneumoniae , Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . The product does not provide adequate coverage against Serratia marcescens ."],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20260204","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 this product is administered to a nursing woman."],"adverse_reactions":["ADVERSE REACTIONS Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in those persons who have shown hypersensitivity to any of its components."],"general_precautions":["As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated. Bacterial resistance to this product 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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin. 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. Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane. Microbiology: Neomycin sulfate, polymyxin B sulfate, and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus , streptococci, including Streptococcus pneumoniae , Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . The product does not provide adequate coverage against Serratia marcescens ."],"indications_and_usage":["INDICATIONS AND USAGE Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution 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."],"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 : Error! Hyperlink reference not valid. ). If the condition persists or gets worse, or if a rash or other 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."],"spl_unclassified_section":["(Sterile) Rx only","Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: August 2022 9113405 (Folded) 9113505 (Flat)"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour. donot"],"spl_product_data_elements":["NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SODIUM CHLORIDE DEHYDRATED ALCOHOL POLOXAMER 188 PROPYLENE GLYCOL AQUA HYDROCHLORIC ACID AMMONIA THIMEROSAL NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B GRAMICIDIN GRAMICIDIN"],"package_label_principal_display_panel":["neomycin sulfate, polymyxin b sulfate and gramicidin Label Image"],"carcinogenesis_and_mutagenesis_and_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 gramicidin. Treatment of cultured 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."]},"tags":[{"label":"gramicidin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Thromboxane-A synthase","category":"target"},{"label":"TBXAS1","category":"gene"},{"label":"LCK","category":"gene"},{"label":"TACR2","category":"gene"},{"label":"R02AB30","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Solution/ Drops","category":"form"},{"label":"Active","category":"status"},{"label":"Bacterial conjunctivitis","category":"indication"},{"label":"Bacterial keratitis","category":"indication"},{"label":"Blepharoconjunctivitis","category":"indication"},{"label":"Infective blepharitis","category":"indication"},{"label":"Superficial Ocular Infection","category":"indication"},{"label":"Monarch Pharms","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Local","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"MACULAR DEGENERATION","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"ANAPHYLACTIC REACTION","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"BRONCHOSPASM","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"DRUG DISPENSING ERROR","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"DRY EYE","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"EAR DISCOMFORT","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"EXPIRED PRODUCT ADMINISTERED","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"1 reports"}],"commonSideEffects":[{"effect":"allergic reactions","drugRate":"reported","severity":"unknown"},{"effect":"itching","drugRate":"reported","severity":"unknown"},{"effect":"swelling","drugRate":"reported","severity":"unknown"},{"effect":"conjunctival erythema","drugRate":"reported","severity":"unknown"},{"effect":"anaphylaxis","drugRate":"reported","severity":"unknown"},{"effect":"local irritation","drugRate":"reported","severity":"unknown"}],"contraindications":["This product is contraindicated in individuals who have shown hypersensitivity to any of its components."],"specialPopulations":{"Pregnancy":"Pregnancy. Teratogenic effects. Pregnancy Category C. Adequate animal reproductive studies have not been conducted with neomycin, polymyxin or gramicidin. It is also not known whether this product can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. This product should be given to pregnant woman only if clearly needed.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GRAMICIDIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:38:26.685923+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:38:33.172429+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:38:25.207775+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GRAMICIDIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:38:34.031968+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:23.959958+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:23.960083+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:38:35.621975+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cell membrane inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:38:34.693552+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201469/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:38:34.581225+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic 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. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-534","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:38.751354+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:41.253834+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA064047","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:38:23.960101+00:00"}},"allNames":"gramoderm","offLabel":[],"synonyms":["gramicidin","gramicidins","gramoderm","gramicidin D","gramicidine","gramicidin Dubos"],"timeline":[{"date":"1968-07-03","type":"positive","source":"DrugCentral","milestone":"FDA approval (Monarch Pharms)"}],"aiSummary":"Gramoderm (Gramicidin) is a small molecule antibiotic developed by Monarch Pharms, targeting thromboxane-A synthase. It is used to treat various bacterial infections of the eye, including conjunctivitis, keratitis, and blepharitis. Gramoderm was FDA-approved in 1968 and remains a proprietary product of Monarch Pharms. Key safety considerations include its potential for ocular irritation and allergic reactions. As a gramicidin antibiotic, Gramoderm works by disrupting bacterial cell membranes.","approvals":[{"date":"1968-07-03","orphan":false,"company":"MONARCH PHARMS","regulator":"FDA"}],"brandName":"Gramoderm","ecosystem":[{"indication":"Bacterial conjunctivitis","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"besifloxacin","slug":"besifloxacin","company":"Bausch And Lomb"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":null},{"indication":"Bacterial keratitis","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":6000000},{"indication":"Blepharoconjunctivitis","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Infective blepharitis","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Superficial Ocular Infection","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"chloramphenicol","slug":"chloramphenicol","company":"Parkedale"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""}],"globalPrevalence":6000000}],"mechanism":{"target":"Thromboxane-A synthase","novelty":"Follow-on","targets":[{"gene":"TBXAS1","source":"DrugCentral","target":"Thromboxane-A synthase","protein":"Thromboxane-A synthase"},{"gene":"LCK","source":"DrugCentral","target":"Tyrosine-protein kinase Lck","protein":"Tyrosine-protein kinase Lck"},{"gene":"TACR2","source":"DrugCentral","target":"Substance-K receptor","protein":"Substance-K receptor"},{"gene":"EDNRA","source":"DrugCentral","target":"Endothelin-1 receptor","protein":"Endothelin-1 receptor"},{"gene":"MC5R","source":"DrugCentral","target":"Melanocortin receptor 5","protein":"Melanocortin receptor 5"},{"gene":"MC4R","source":"DrugCentral","target":"Melanocortin receptor 4","protein":"Melanocortin receptor 4"},{"gene":"FYN","source":"DrugCentral","target":"Tyrosine-protein kinase Fyn","protein":"Tyrosine-protein kinase Fyn"}],"modality":"Small Molecule","drugClass":"gramicidin","explanation":"","oneSentence":"","technicalDetail":"Gramoderm, a gramicidin antibiotic, exerts its antibacterial effect by forming a voltage-dependent ion channel in the bacterial cell membrane, leading to an influx of cations and subsequent cell death."},"commercial":{"launchDate":"1968","_launchSource":"DrugCentral (FDA 1968-07-03, MONARCH PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4794","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=GRAMICIDIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GRAMICIDIN","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T11:48:02.951095","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:38:42.323490+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"neomycin","drugSlug":"neomycin","fdaApproval":"1957-03-26","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"bacitracin","drugSlug":"bacitracin","fdaApproval":"1948-07-29","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"gramicidin","indications":{"approved":[{"name":"Bacterial conjunctivitis","source":"DrugCentral","snomedId":128350005,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Bacterial keratitis","source":"DrugCentral","snomedId":314557000,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned","usPrevalence":null,"globalPrevalence":6000000,"prevalenceMethod":"curated","prevalenceSource":"Cochrane Database Syst Rev, 2025 (PMID:40728038)"},{"name":"Blepharoconjunctivitis","source":"DrugCentral","snomedId":68659002,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Infective blepharitis","source":"DrugCentral","snomedId":312219000,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Superficial Ocular Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No specific eligibility criteria mentioned","usPrevalence":null,"globalPrevalence":6000000,"prevalenceMethod":"curated","prevalenceSource":"Cochrane Database Syst Rev, 2025 (PMID:40728038)"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"neomycin","brandName":"neomycin","genericName":"neomycin","approvalYear":"1957","relationship":"same-class"},{"drugId":"bacitracin","brandName":"bacitracin","genericName":"bacitracin","approvalYear":"1948","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06859281","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers","status":"RECRUITING","sponsor":"Valenta Pharm JSC","startDate":"2024-12-10","conditions":["Pharyngitis"],"enrollment":24,"completionDate":"2026-12-01"},{"nctId":"NCT06843018","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges","status":"RECRUITING","sponsor":"Valenta Pharm JSC","startDate":"2024-11-14","conditions":["Pharyngitis Acute","Pharyngitis","Nasopharyngitis","Exacerbation of Chronic Pharyngitis"],"enrollment":300,"completionDate":"2026-12-31"},{"nctId":"NCT06857890","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers","status":"RECRUITING","sponsor":"Valenta Pharm JSC","startDate":"2024-12-09","conditions":["Pharyngitis"],"enrollment":24,"completionDate":"2026-12-01"},{"nctId":"NCT04323475","phase":"PHASE1","title":"Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients","status":"UNKNOWN","sponsor":"Precisio Biotix Therapeutics, Inc.","startDate":"2022-01","conditions":["Wound Infection"],"enrollment":12,"completionDate":"2023-08"},{"nctId":"NCT01950598","phase":"NA","title":"Frozen Versus Fresh Corneal Carriers for the Boston KPro Type I Donor Carriers","status":"COMPLETED","sponsor":"Marie-Claude Robert","startDate":"2013-09","conditions":["Corneal Blindness","Boston Keratoprosthesis Type I Candidate"],"enrollment":37,"completionDate":"2020-11"},{"nctId":"NCT00990392","phase":"NA","title":"Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections","status":"WITHDRAWN","sponsor":"Fraser Health","startDate":"2009-11","conditions":["Blood Stream Infections","Skin Diseases, Infectious"],"enrollment":0,"completionDate":"2011-01"},{"nctId":"NCT01809483","phase":"PHASE3","title":"Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients","status":"COMPLETED","sponsor":"Udayana University","startDate":"2012-09","conditions":["Erosion; Cornea, Traumatic"],"enrollment":32,"completionDate":"2013-02"},{"nctId":"NCT01524744","phase":"PHASE2","title":"A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus","status":"UNKNOWN","sponsor":"Mashhad University of Medical Sciences","startDate":"2009-03","conditions":["Oral Lichen Planus"],"enrollment":40,"completionDate":"2012-12"},{"nctId":"NCT00534391","phase":"PHASE3","title":"Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage","status":"UNKNOWN","sponsor":"Chulalongkorn University","startDate":"2007-09","conditions":["Hordeolum"],"enrollment":120,"completionDate":"2008-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Ophthalmic","formulation":"Solution/ Drops","formulations":[{"form":"SOLUTION/ DROPS","route":"OPHTHALMIC","productName":"NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN"},{"form":"SOLUTION/ DROPS","route":"OPHTHALMIC","productName":"Neomycin and Polymyxin B Sulfates and Gramicidin"}]},"crossReferences":{"NUI":"N0000147077","MMSL":"4800","NDDF":"002801","UNII":"5IE62321P4","VUID":"4018774","CHEBI":"CHEBI:5530","VANDF":"4018774","INN_ID":"2025","RXNORM":"5011","UMLSCUI":"C0018165","chemblId":"CHEMBL1201469","ChEMBL_ID":"CHEMBL1201469","KEGG_DRUG":"D04369","DRUGBANK_ID":"DB00027","PUBCHEM_CID":"16132269","SNOMEDCT_US":"387524003","SECONDARY_CAS_RN":"113-73-5","MESH_DESCRIPTOR_UI":"D006096"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1968-","companyName":"Monarch Pharms","relationship":"Original Developer"}],"publicationCount":3718,"therapeuticAreas":["Cardiovascular"],"atcClassification":{"source":"DrugCentral","atcCode":"R02AB30","allCodes":["R02AB30"]},"biosimilarFilings":[],"originalDeveloper":"Monarch Pharms","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Small Molecule","firstApprovalDate":"1968","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1968-07-03T00:00:00.000Z","mah":"MONARCH PHARMS","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2001-03-07T00:00:00.000Z","mah":"BAUSCH AND LOMB","brand_name_local":null,"application_number":"ANDA064047"},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:38:42.323490+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}