{"id":"acetic-acid","rwe":[{"pmid":"41905949","year":"2026","title":"Establishment of Irinotecan-Induced Oral Mucositis Hamster Model and Evaluation of Therapeutic Agents.","finding":"","journal":"Biological & pharmaceutical bulletin","studyType":"Clinical Study"},{"pmid":"41905895","year":"2026","title":"Fungus Derived Indole-3-Acetic Acid Controls Developmental Conidial Death in Magnaporthe oryzae.","finding":"","journal":"Molecular plant pathology","studyType":"Clinical Study"},{"pmid":"41905673","year":"2026","title":"Accelerated acidogenic fermentation and sulfate reduction with mariculture solid waste by magnetite-modified three-dimensional electro-fermentation system.","finding":"","journal":"Bioresource technology","studyType":"Clinical Study"},{"pmid":"41905273","year":"2026","title":"Recycling high-performance glass fibers from waste wind turbine blades via an acetic acid/nitric acid system.","finding":"","journal":"Waste management (New York, N.Y.)","studyType":"Clinical Study"},{"pmid":"41905241","year":"2026","title":"Fermentation kinetics of Pichia kluyveri-Saccharomyces cerevisiae in Nebbiolo must.","finding":"","journal":"International journal of food microbiology","studyType":"Clinical Study"}],"_fda":{"id":"2a4574f2-001a-ad0a-e063-6394a90a98f6","set_id":"0c5ebd59-0e98-4ea1-b279-9202a19f6dbf","openfda":{"unii":["Q40Q9N063P"],"route":["AURICULAR (OTIC)"],"rxcui":["197305"],"spl_id":["2a4574f2-001a-ad0a-e063-6394a90a98f6"],"brand_name":["Acetic Acid"],"spl_set_id":["0c5ebd59-0e98-4ea1-b279-9202a19f6dbf"],"package_ndc":["52817-816-15"],"product_ndc":["52817-816"],"generic_name":["ACETIC ACID"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ACETIC ACID"],"manufacturer_name":["TruPharma, LLC"],"application_number":["ANDA040607"],"is_original_packager":[true]},"version":"2","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."],"description":["DESCRIPTION Acetic acid otic solution, USP is a solution of acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid. The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic acid otic solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Chemical Structure"],"precautions":["PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear."],"how_supplied":["HOW SUPPLIED Acetic acid otic solution, USP, containing 2% acetic acid, is available in 15 mL measured‑drop, safety-tip plastic bottles. NDC 52817-816-15 15 mL Bottle"],"pediatric_use":["PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 years have not been established."],"effective_time":"20241227","adverse_reactions":["ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1­800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to acetic acid otic solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal."],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev. 03/20-R1"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Acetic acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues."],"indications_and_usage":["INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial."],"spl_unclassified_section":["Rx only"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow acetic acid otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid otic solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal."],"spl_product_data_elements":["Acetic Acid Acetic Acid PROPYLENE GLYCOL BENZETHONIUM CHLORIDE PROPYLENE GLYCOL DIACETATE SODIUM ACETATE ANHYDROUS CITRIC ACID ACETIC ACID ACETIC ACID"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 52817-816-15 Acetic Acid Otic Solution USP, 2% Rx only 15 mL Label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 52817-816-15 Acetic Acid Otic Solution USP, 2% Rx only 15 mL Carton"]},"tags":[{"label":"acetic acid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Tyrosine-protein kinase Lck","category":"target"},{"label":"LCK","category":"gene"},{"label":"FYN","category":"gene"},{"label":"FFAR3","category":"gene"},{"label":"G01AD02","category":"atc"},{"label":"Cutaneous","category":"route"},{"label":"Irrigation","category":"route"},{"label":"Oral","category":"route"},{"label":"Gel","category":"form"},{"label":"Irrigant","category":"form"},{"label":"Jelly","category":"form"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Otitis externa","category":"indication"},{"label":"Hikma","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Indicators and Reagents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"35 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"29 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"28 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"22 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"21 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"20 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"18 reports"}],"commonSideEffects":[{"effect":"local irritation","drugRate":"very rarely","severity":"unknown"},{"effect":"stinging","drugRate":"occasionally","severity":"mild"},{"effect":"burning","drugRate":"occasionally","severity":"mild"}],"contraindications":["Fungal ear infection","Herpes simplex","Herpes zoster auricularis","Infective otitis media","Perforation of tympanic membrane","Porphyria","Sensation Disturbance of Genitals","Tuberculosis of ear","Viral ear infection"],"specialPopulations":{"Pregnancy":"Pregnancy Category C. Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation USP. It is also not known whether 0.25% Acetic Acid Irrigation USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation USP should be given to pregnant woman only if clearly needed.","Geriatric use":"Clinical studies of 0.25% Acetic Acid Irrigation USP have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Although systemic absorption of the product is unlikely, greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Hikma","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.4042/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$505","description":"ACETIC ACID 2% EAR SOLUTION","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ACETIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:13:28.127323+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:13:34.644698+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:13:26.761033+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ACETIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:13:35.323193+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:13:24.194810+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:13:45.705535+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:13:24.194848+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":"2026-04-20T03:13:37.816791+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL539/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:13:36.476100+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040607","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:13:24.194857+00:00"}},"allNames":"hydrocortisone and acetic acid","offLabel":[],"synonyms":["acetic acid","acetic acid, glacial","ethanoic acid","ethylic acid","vinegar acid"],"timeline":[{"date":"1960-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HI TECH PHARMA to Hikma"},{"date":"1960-05-17","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hi Tech Pharma)"},{"date":"1982-02-19","type":"positive","source":"FDA Orange Book","milestone":"Acetic Acid 0.25% In Plastic Container approved — 250MG/100ML"}],"aiSummary":"Hydrocortisone and Acetic Acid, originally developed by HI TECH PHARMA and currently owned by Hikma, is a small molecule acetic acid drug class targeting Tyrosine-protein kinase Lck. It was FDA approved in 1960 for the treatment of otitis externa. The drug is off-patent with 7 generic manufacturers, indicating it is commercially available as a generic product. Key safety considerations include the potential for local skin irritation and allergic reactions. This medication works by reducing inflammation and infection in the affected ear.","brandName":"Hydrocortisone And Acetic Acid","ecosystem":[{"indication":"Otitis externa","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"chloramphenicol","slug":"chloramphenicol","company":"Parkedale"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":null}],"mechanism":{"target":"Tyrosine-protein kinase Lck","novelty":"Follow-on","targets":[{"gene":"LCK","source":"DrugCentral","target":"Tyrosine-protein kinase Lck","protein":"Tyrosine-protein kinase Lck"},{"gene":"FYN","source":"DrugCentral","target":"Tyrosine-protein kinase Fyn","protein":"Tyrosine-protein kinase Fyn"},{"gene":"FFAR3","source":"DrugCentral","target":"Free fatty acid receptor 3","protein":"Free fatty acid receptor 3"},{"gene":"FFAR2","source":"DrugCentral","target":"Free fatty acid receptor 2","protein":"Free fatty acid receptor 2"}],"modality":"Small Molecule","drugClass":"acetic acid","explanation":"","oneSentence":"","technicalDetail":"Hydrocortisone, a corticosteroid, exerts its anti-inflammatory effects by inhibiting the production of pro-inflammatory cytokines, while Acetic Acid, a weak organic acid, exhibits antimicrobial properties by disrupting bacterial cell membranes and interfering with their metabolic processes."},"commercial":{"launchDate":"1960","_launchSource":"DrugCentral (FDA 1960-05-17, HI TECH PHARMA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4211","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ACETIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ACETIC ACID","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:23:03.904956","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:13:45.973949+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"lactic acid","drugSlug":"lactic-acid","fdaApproval":"","relationship":"same-class"},{"drugName":"ascorbic acid","drugSlug":"ascorbic-acid","fdaApproval":"","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"acetic acid","indications":{"approved":[{"id":"acetic-acid-superficial-external-auditory-","name":"Superficial external auditory canal infections","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with superficial infections of the external auditory canal","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with superficial infections of the external auditory canal","diagnosticRequired":null,"brandNameForIndication":"Hydrocortisone And Acetic Acid"}],"offLabel":[{"name":"Impacted cerumen","source":"DrugCentral","drugName":"ACETIC ACID","evidenceCount":3,"evidenceLevel":"emerging"},{"name":"Otalgia","source":"DrugCentral","drugName":"ACETIC ACID","evidenceCount":22,"evidenceLevel":"moderate"},{"name":"Otitis Externa Eczema","source":"DrugCentral","drugName":"ACETIC ACID","evidenceCount":6,"evidenceLevel":"emerging"},{"name":"Otitis Externa Seborrhea","source":"DrugCentral","drugName":"ACETIC 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