{"id":"fumaria","rwe":[],"_fda":{"id":"9ae962a2-0cab-4662-b6ee-f0a2c4fb5d79","set_id":"1bae3b06-ad71-4ef1-b64a-ef700f9fab62","openfda":{"nui":["N0000185371","N0000185375","N0000175629","N0000184306","N0000185001","M0000728","M0006342","M0016962","M0516536"],"upc":["0371753901112"],"unii":["7M867G6T1U","59677RXH25","4110YT348C","VH659J61ZL","ZW3Z11D0JV","3C18L6RJAZ","02F3473H9O","RP8496915M","CLF5YFS11O","5405K23S50","1NT28V9397"],"route":["ORAL"],"spl_id":["9ae962a2-0cab-4662-b6ee-f0a2c4fb5d79"],"brand_name":["Detox Escort"],"spl_set_id":["1bae3b06-ad71-4ef1-b64a-ef700f9fab62"],"package_ndc":["71753-9011-1"],"product_ndc":["71753-9011"],"generic_name":["AESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, MAGNESIA MURIATICA, LINUM USITATISSIMUM, PASSIFLORA INCARNATA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, FUMARIA OFFICINALIS, ONONIS SPINOSA"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"substance_name":["CENTELLA ASIATICA WHOLE","EQUISETUM HYEMALE WHOLE","FLAX SEED","FUMARIA OFFICINALIS FLOWERING TOP","GOLDENSEAL","HORSE CHESTNUT","MAGNESIUM CHLORIDE","ONONIS SPINOSA WHOLE","PASSIFLORA INCARNATA FLOWERING TOP","SOLIDAGO VIRGAUREA FLOWERING TOP","THUJA OCCIDENTALIS LEAFY TWIG"],"pharm_class_epc":["Non-Standardized Food Allergenic Extract [EPC]","Non-Standardized Plant Allergenic Extract [EPC]"],"manufacturer_name":["Ratis, LLC"],"is_original_packager":[true]},"purpose":["PURPOSE: Aesculus Hippocastanum – Detox of colon, portal system,* Equisetum Hyemale – bladder, kidneys,* Hydrastis Canadensis – sinuses, lungs,* Hydrocotyle Asiatica – lymph, skin, connective tissue,* Magnesia Muriatica - liver,* Linum Usitatissimum – mucous membranes,* Passiflora Incarnata – nervous system,* Solidago Virgaurea – bladder kidneys,* Thuja Occidentalis – intestine, skin,* Fumaria Officinalis – liver, gallbladder,* Ononis Spinosa – urinary system.*"],"version":"2","warnings":["WARNINGS: For oral use only. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING"],"questions":["QUESTIONS: www.HomeopathyStore.com (888) 405-7551 Dist. by Ratis, LLC, 1201 N Orange St, Ste 7594 Wilmington, De 19801"],"effective_time":"20240927","active_ingredient":["ACTIVE INGREDIENTS: (in each drop) Aesculus Hippocastanum 6X 9.09%, Equisetum Hyemale 6X 9.09%, Hydrastis Canadensis 6X 9.09%, Hydrocotyle Asiatica 6X 9.09%, Magnesia Muriatica 6X 9.09%, Linum Usitatissimum 6X 9.09%, Passiflora Incarnata 6X 9.09%, Solidago Virgaurea 6X 9.09%, Thuja Occidentalis 6X 9.09%, Fumaria Officinalis 8X 9.09%, Ononis Spinosa 6C 9.09%."],"inactive_ingredient":["INACTIVE INGREDIENTS: Demineralized water, organic ethanol 20%"],"indications_and_usage":["USES: May temporarily relieve symptoms of general toxicity such as fatigue, increased mucus, abdominal bloating, constipation alternating with diarrhea, skin conditions, muscle stiffness, soreness, pain.* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"dosage_and_administration":["DIRECTIONS: 4 sprays under tongue or in half a cup of water morning and evening. Consult a physician for use in children under 12 years of age. Store in a cool, dry place."],"spl_product_data_elements":["Detox Escort Aesculus Hippocastanum, Equisetum Hyemale, Hydrastis Canadensis, Hydrocotyle Asiatica, Magnesia Muriatica, Linum Usitatissimum, Passiflora Incarnata, Solidago Virgaurea, Thuja Occidentalis, Fumaria Officinalis, Ononis Spinosa HORSE CHESTNUT HORSE CHESTNUT EQUISETUM HYEMALE WHOLE EQUISETUM HYEMALE GOLDENSEAL GOLDENSEAL CENTELLA ASIATICA WHOLE CENTELLA ASIATICA MAGNESIUM CHLORIDE MAGNESIUM CATION FLAX SEED FLAX SEED PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG FUMARIA OFFICINALIS FLOWERING TOP FUMARIA OFFICINALIS FLOWERING TOP ONONIS SPINOSA WHOLE ONONIS CAMPESTRIS WATER ALCOHOL"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN: In case of overdose, contact physician or Poison Control Center right away."],"package_label_principal_display_panel":["PACKAGE LABEL DISPLAY: LACTOSE FREE ANNA KARE Detox Escort DETOX OF ELIMINATION CENTERS* HOMEOPATHIC ORAL SPRAY 1 FL. OZ (30ML) Detox Escort"]},"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"33 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"33 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"30 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"29 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"27 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"24 reports"},{"date":"","signal":"PAIN IN EXTREMITY","source":"FDA FAERS","actionTaken":"22 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"ABDOMINAL PAIN UPPER","source":"FDA FAERS","actionTaken":"17 reports"}]},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Fumaria","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:23:03.093953+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:23:25.231927+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:23:10.988711+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Fumaria","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:23:12.366877+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:23:00.863512+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:23:00.863566+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:23:20.195692+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:23:00.863577+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":"2026-04-20T01:23:13.804195+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"5ff0e58c-d745-4c92-aef6-4f40168a4935","title":"D-60 (CALCIUM SULFIDE, JUGLANS REGIA FRUIT RIND, IMMATURE, JUGLANS REGIA LEAF, MYOSOTIS ARVENSIS, SMILAX ORNATA ROOT, FUMARIA OFFICINALIS FLOWERING TOP, ARANEUS DIADEMATUS, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, AND GALIUM APARINE) SOLUTION [DNA LABS, INC.]"},"aiSummary":"Fumaria, marketed by Shiraz University of Medical Sciences, is positioned in the general toxicity symptom relief segment. The drug's key composition patent is set to expire in 2028, providing a period of exclusivity and potential market protection. The primary risk lies in the lack of detailed clinical trial results and revenue data, which may limit investor confidence and market adoption.","ecosystem":[],"mechanism":{"drugClass":"Non-Standardized Food Allergenic Extract [EPC]"},"_scrapedAt":"2026-03-28T03:33:22.718Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T01:23:25.232276+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"indications":{"approved":[{"id":"fumaria-general-toxicity-symptom-relie","name":"General toxicity symptom relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02671162","phase":"PHASE2","title":"Evaluating the Effect of Fumaria Parviflora L. in Uremic Pruritus","status":"COMPLETED","sponsor":"Shiraz University of Medical Sciences","startDate":"2015-07","conditions":"End-Stage Renal Disease, Pruritus","enrollment":63}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":192,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Fumaria","genericName":"Fumaria","companyName":"Shiraz University of Medical Sciences","companyId":"shiraz-university-of-medical-sciences","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T01:23:25.232276+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}