{"id":"tetracaine","rwe":[],"_fda":{"id":"35bf62a6-b5a0-9582-e063-6394a90a1b92","set_id":"01fba5f8-a60a-444c-9abd-299540b8815a","openfda":{"unii":["5NF5D4OPCI"],"route":["OPHTHALMIC"],"rxcui":["1547771"],"spl_id":["35bf62a6-b5a0-9582-e063-6394a90a1b92"],"brand_name":["Tetracaine Hydrochloride"],"spl_set_id":["01fba5f8-a60a-444c-9abd-299540b8815a"],"package_ndc":["70518-4183-1","70518-4183-0"],"product_ndc":["70518-4183"],"generic_name":["TETRACAINE HYDROCHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["TETRACAINE HYDROCHLORIDE"],"manufacturer_name":["REMEDYREPACK INC."],"application_number":["NDA208135"],"original_packager_product_ndc":["0065-0741"]},"version":"2","pregnancy":["8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature."],"overdosage":["10 OVERDOSAGE Prolonged use of a topical ocular anesthetic including TetracaineHydrochloride Ophthalmic Solution 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss. Symptoms related to systemic toxicity consist mainly of effects on the neurologic and cardiovascular systems."],"description":["11 DESCRIPTION Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15 H 24 N 2 O 2 • HCl and it is represented by the chemical structure: Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5. Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine) Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP Chemical Diagram"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNITS® is supplied as single patient use, 4 mL filled in 4-mL natural medium- or low-density polyethylene plastic DROP-TAINER® dispensers and natural low-density polyethylene tips with white polypropylene caps in a carton of 12. Each sterilized DROP-TAINER® dispenser is packaged in a clear PVC and Tyvek blister. This product does not contain a preservative; discard unused portion. NDC: 70518-4183-00 NDC: 70518-4183-01 PACKAGING: 12 in 2 CARTON PACKAGING: 1-4 mL BOTTLE, DROPPER TYPE 0 Storage: Store at 2°C to 25°C (36°F to 77°F). Protect from light. Do not use if solution contains crystals, is cloudy, or discolored. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762"],"geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients."],"pediatric_use":["8.4 Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population."],"effective_time":"20250522","clinical_studies":["14 CLINICAL STUDIES Topical administration of tetracainehydrochloride ophthalmic solution results in localized temporary anesthesia. The maximum effect is achieved within 10–20 seconds after instillation, with efficacy lasting 10–20 minutes. Duration of effect can be extended with repeated dosing. [see Corneal toxicity (5.2) and Overdosage (10) ] ."],"pharmacokinetics":["12.3 Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues."],"adverse_reactions":["6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal injury with Intracameral Use [See Warnings and Precautions (5.1) ] Corneal Toxicity [See Warnings and Precautions (5.2) ] Corneal Injury due to Insensitivity [ See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution 0.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. Ocular adverse events: stinging, burning, conjunctival redness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["4 CONTRAINDICATIONS None. None ( 4 )"],"mechanism_of_action":["12.1 Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia."],"recent_major_changes":["Warnings and Precautions ( 5.4 ) 2/2022",""],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia. 12.3 Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues."],"indications_and_usage":["1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Do not use intracamerally since use may damage corneal endothelial cells ( 5.1 ) Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. ( 5.2 ) Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.3 ) For Administration by Healthcare Provider: Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration. ( 5.4 ) 5.1 Corneal injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 0.5% may lead to damage of the corneal endothelial cells. 5.2 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. 5.3 Corneal Injury due to Insensitivity Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. 5.4 For Administration by Healthcare Provider Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration [ see Warnings and Precautions ( 5.2 )]."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Eye Care Precaution Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive up to 20 minutes and that care should be taken to avoid accidental injuries. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1 ) 2.1 Topical Administration One drop topically in the eye as needed. Discard unused portion. 2.2 Sterile Field Administration Open package using standard aseptic technique. The DROP‑TAINER ® dispenser may then be allowed to fall upon a sterile surface. The entire outer surface of the DROP‑TAINER ® dispenser and its contents are sterile."],"spl_product_data_elements":["Tetracaine Hydrochloride tetracaine hydrochloride SODIUM CHLORIDE SODIUM ACETATE ACETIC ACID WATER TETRACAINE HYDROCHLORIDE TETRACAINE"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Sterile ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v. Sterile ophthalmic solution containing 0.5% tetracaine hydrochloride ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. 8.2 Lactation Risk Summary There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available. 8.4 Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. 8.5 Geriatric Use No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients."],"package_label_principal_display_panel":["DRUG: Tetracaine Hydrochloride GENERIC: tetracaine hydrochloride DOSAGE: SOLUTION ADMINSTRATION: OPHTHALMIC NDC: 70518-4183-0 NDC: 70518-4183-1 PACKAGING: 4 mL in 1 BOTTLE, DROPPER OUTER PACKAGING: 12 in 1 CARTON ACTIVE INGREDIENT(S): Tetracaine Hydrochloride 5mg in 1mL INACTIVE INGREDIENT(S): Sodium Chloride Sodium Acetate Acetic Acid Water MM1 MM2"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature."]},"tags":[{"label":"Ester Local Anesthetic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sodium channel protein type 7 subunit alpha","category":"target"},{"label":"SCN7A","category":"gene"},{"label":"MAOA","category":"gene"},{"label":"SCN9A","category":"gene"},{"label":"C05AD02","category":"atc"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Administration of Corneal Anesthesia","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Local Anesthesia for Ophthalmologic Procedure","category":"indication"},{"label":"Local anesthesia","category":"indication"},{"label":"Local anesthetic intrathecal block","category":"indication"},{"label":"Minor Skin Wound Pain","category":"indication"},{"label":"Alcon Labs","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anesthetics","category":"pharmacology"},{"label":"Anesthetics, Local","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":273.289,"date":"","count":45,"signal":"Toxic anterior segment syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 45 times (LLR=273)"},{"llr":156.138,"date":"","count":19,"signal":"Aqueous fibrin","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=156)"},{"llr":135.733,"date":"","count":29,"signal":"Endophthalmitis","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=136)"},{"llr":100.301,"date":"","count":17,"signal":"Suspected transmission of an infectious agent via product","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=100)"},{"llr":68.43,"date":"","count":23,"signal":"Visual acuity reduced","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=68)"},{"llr":65.865,"date":"","count":21,"signal":"Eye irritation","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=66)"},{"llr":61.671,"date":"","count":29,"signal":"Inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=62)"},{"llr":61.626,"date":"","count":11,"signal":"Hypopyon","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=62)"},{"llr":58.043,"date":"","count":22,"signal":"Eye pain","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=58)"},{"llr":54.48,"date":"","count":14,"signal":"Eye inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=54)"},{"llr":46.235,"date":"","count":10,"signal":"Corneal oedema","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=46)"},{"llr":45.212,"date":"","count":7,"signal":"Corneal infiltrates","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=45)"},{"llr":44.053,"date":"","count":12,"signal":"Vitreous floaters","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=44)"},{"llr":42.152,"date":"","count":7,"signal":"Bulimia nervosa","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=42)"}],"commonSideEffects":[{"effect":"Allergic cornea reaction","drugRate":"reported","severity":"unknown"},{"effect":"Conjunctival redness","drugRate":"reported","severity":"unknown"},{"effect":"Stinging","drugRate":"reported","severity":"unknown"},{"effect":"Burning","drugRate":"reported","severity":"unknown"}],"contraindications":["Conduction disorder of the heart","Decreased respiratory function","Deficiency of cholinesterase","Denuded skin","Disease of liver","Disorder of cardiovascular system","Eye infection","Heart disease","Hyperthyroidism","Kidney disease","Magnetic resonance imaging","Myasthenia gravis","Open wound","Seizure disorder","Uveitis"],"specialPopulations":{"Lactation":"There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion.","Pregnancy":"There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. It is not known whether tetracaine hydrochloride can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Tetracaine hydrochloride should be given to pregnant woman only if clearly needed and the potential benefits outweigh the risk.","Geriatric use":"No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.","Pediatric use":"Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population."}},"trials":[],"aliases":[],"company":"Alcon Labs","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-04-17","unitCost":"$4.4973/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$1,619","description":"TETRACAINE 0.5% EYE DROP","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TETRACAINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:37:15.696104+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:37:42.336231+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:37:23.165105+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TETRACAINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:37:24.017285+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:37:13.612260+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:37:35.682052+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:37:13.612312+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Sodium channel alpha subunit blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:37:24.572923+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1255654/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:37:24.479040+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA208135","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:37:13.612319+00:00"}},"allNames":"tetracaine hydrochloride","offLabel":[],"synonyms":["tetracaine monohydrochloride","pontocaine","tetracaine","amethocaine","laudocaine","tetracaine hydrochloride","tetracaine HCl"],"timeline":[{"date":"2005-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from GALEN SPECIALTY to Alcon Labs"},{"date":"2005-06-23","type":"positive","source":"DrugCentral","milestone":"FDA approval (Galen Specialty)"},{"date":"2019-03-12","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Bausch Lomb Ireland)"},{"date":"2024-12-20","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Tetracaine Hydrochloride, marketed by Alcon Labs, is a topical ophthalmic anesthetic currently generating revenue in a competitive market dominated by same-class drugs such as lidocaine and procaine. Its key strength lies in its mechanism of action, effectively blocking sodium channels in nerve cells to prevent pain signals, which provides reliable anesthesia for ophthalmic procedures. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics and potentially erode market share.","approvals":[{"date":"2005-06-23","orphan":false,"company":"GALEN SPECIALTY","regulator":"FDA"}],"brandName":"Tetracaine Hydrochloride","ecosystem":[{"indication":"Administration of Corneal Anesthesia","otherDrugs":[{"name":"proparacaine","slug":"proparacaine","company":""}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Local Anesthesia for Ophthalmologic Procedure","otherDrugs":[{"name":"bupivacaine","slug":"bupivacaine","company":"Hospira"},{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi 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irritation","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"aluminum acetate","slug":"aluminum-acetate","company":"Bayer Pharms"},{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"benzethonium","slug":"benzethonium","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Sodium channel protein type 7 subunit alpha","novelty":"Follow-on","targets":[{"gene":"SCN7A","source":"DrugCentral","target":"Sodium channel protein type 7 subunit alpha","protein":"Sodium channel protein type 7 subunit alpha"},{"gene":"MAOA","source":"DrugCentral","target":"Amine oxidase [flavin-containing] A","protein":"Amine oxidase [flavin-containing] A"},{"gene":"SCN9A","source":"DrugCentral","target":"Sodium channel protein type 9 subunit alpha","protein":"Sodium channel protein type 9 subunit alpha"},{"gene":"SCN5A","source":"DrugCentral","target":"Sodium channel protein type 5 subunit alpha","protein":"Sodium channel protein type 5 subunit 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required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.","oneSentence":"Tetracaine Hydrochloride works by blocking sodium channels in nerve cells to prevent pain signals from being transmitted.","technicalDetail":"Tetracaine Hydrochloride acts as a sodium channel blocker, specifically targeting the voltage-gated sodium channel NaV1.7, to inhibit the initial depolarization of nerve cells and prevent the transmission of pain signals."},"commercial":{"launchDate":"2005","_launchSource":"DrugCentral (FDA 2005-06-23, GALEN SPECIALTY)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2610","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TETRACAINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TETRACAINE","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":"2026-03-30T15:51:57.401027","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:37:42.337009+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"lidocaine","drugSlug":"lidocaine","fdaApproval":"1948-11-19","patentExpiry":"May 10, 2031","patentStatus":"Patent 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