{"id":"arginine","rwe":[],"_fda":{"id":"5976d173-abc7-4418-a6e5-4bc19937b657","set_id":"04cded9a-0431-4e87-9055-ec4f38112559","openfda":{"unii":["94ZLA3W45F","O80TY208ZW","CUQ3A77YXI","7A7G0PQI12","Z4B6561488","T7S323PKJS","U946SH95EE","6EC706HI7F","ABS794681C","L0PFEMQ1DT","39981FM375","1NT28V9397","RQ2CFA7WWJ"],"route":["ORAL"],"spl_id":["5976d173-abc7-4418-a6e5-4bc19937b657"],"brand_name":["VITAL II"],"spl_set_id":["04cded9a-0431-4e87-9055-ec4f38112559"],"package_ndc":["50845-0257-1","50845-0257-2"],"product_ndc":["50845-0257"],"generic_name":["ARNICA MONTANA, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, L-ARGININE, OLEUM ANIMALE, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ARGININE","ARNICA MONTANA WHOLE","ASIAN GINSENG","CERVUS ELAPHUS HORN OIL","GALIUM APARINE WHOLE","HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK","MILK THISTLE","PORK LIVER","SCHISANDRA CHINENSIS FRUIT","SUS SCROFA PITUITARY GLAND","TARAXACUM OFFICINALE","THUJA OCCIDENTALIS LEAFY TWIG","TURNERA DIFFUSA LEAFY TWIG"],"manufacturer_name":["Liddell Laboratories, Inc."],"is_original_packager":[true]},"purpose":["USES: Temporarily relieves these symptoms due to aging and/or a run-down condition: • low energy • poor muscle/fat balance • occasional sleeplessness"],"version":"3","warnings":["WARNINGS: Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have consistent sleeplessness that persists for more than two weeks. Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Store at room temperature."],"questions":["QUESTIONS: DISTRIBUTED BY: Liddell Laboratories 201 Apple Blvd Woodbine, IA 51579 www.liddell.net 1-800-460-7733"],"effective_time":"20240701","active_ingredient":["ACTIVE INGREDIENTS: (in each spray) 7.69% of Arnica Montana 3X, Carduus Marianus 3X, Damiana 3X, Galium Aparine 3X, Hamamelis Virginiana 3X, Hepar Suis 6X, Hypophysis Suis 6X, Panax Ginseng 3X, L-Arginine 6X, Oleum Animale 15X, Schisandra Chinensis 3X, Taraxacum Officinale 3X, Thuja Occidentalis 200C."],"inactive_ingredient":["INACTIVE INGREDIENTS: Purified Water, Organic Ethanol 20%"],"indications_and_usage":["USES: Temporarily relieves these symptoms due to aging and/or a run-down condition: • low energy • poor muscle/fat balance • occasional sleeplessness"],"dosage_and_administration":["DIRECTIONS: Adults only. Spray twice under the tongue three times a day."],"spl_product_data_elements":["VITAL II Arnica Montana, Carduus Marianus, Damiana, Galium Aparine, Hamamelis Virginiana, Hepar Suis, Hypophysis Suis, Panax Ginseng, L-Arginine, Oleum Animale, Schisandra Chinensis, Taraxacum Officinale, Thuja Occidentalis ARNICA MONTANA WHOLE ARNICA MONTANA MILK THISTLE MILK THISTLE TURNERA DIFFUSA LEAFY TWIG TURNERA DIFFUSA LEAFY TWIG GALIUM APARINE WHOLE GALIUM APARINE HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PORK LIVER PORK LIVER SUS SCROFA PITUITARY GLAND SUS SCROFA PITUITARY GLAND ASIAN GINSENG ASIAN GINSENG ARGININE ARGININE CERVUS ELAPHUS HORN OIL CERVUS ELAPHUS HORN OIL SCHISANDRA CHINENSIS FRUIT SCHISANDRA CHINENSIS FRUIT TARAXACUM OFFICINALE TARAXACUM OFFICINALE THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG WATER ALCOHOL"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN: Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away."],"package_label_principal_display_panel":["PACKAGE LABEL DISPLAY: VITÀL II HORMONE FREE with ginseng extract AGE DEFYING Restores youthful energy, burns fat, improves sleep. DOCTOR FORMULATED Readily absorbed. Safe. No known side effects. Easy to use HOMEOPATHIC FAST ACTING ORAL SPRAY LIDDELL 1.0 FL OZ (30 ml) Vital II lbl Vital II ctn"]},"tags":[{"label":"arginine hydrochloride","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Nitric oxide synthase, inducible","category":"target"},{"label":"NOS2","category":"gene"},{"label":"GPRC6A","category":"gene"},{"label":"B05XB01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Diagnostic Test for Growth Hormone Secretion","category":"indication"},{"label":"Renal radiation exposure from Lutetium (177Lu) oxodotreotide","category":"indication"},{"label":"Pharmacia And Upjohn","category":"company"},{"label":"Approved 1970s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":138.837,"date":"","count":18,"signal":"Hyperammonaemic crisis","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=139)"},{"llr":81.824,"date":"","count":41,"signal":"Haematuria","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=82)"},{"llr":54.901,"date":"","count":11,"signal":"Blindness cortical","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=55)"},{"llr":51.012,"date":"","count":27,"signal":"Premature baby","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=51)"},{"llr":50.475,"date":"","count":17,"signal":"Hyperammonaemia","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=50)"},{"llr":43.432,"date":"","count":16,"signal":"Foetal growth restriction","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=43)"},{"llr":35.397,"date":"","count":12,"signal":"Ammonia increased","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=35)"},{"llr":30.926,"date":"","count":8,"signal":"Infantile apnoea","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=31)"},{"llr":29.725,"date":"","count":10,"signal":"Device related sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=30)"},{"llr":28.666,"date":"","count":7,"signal":"Blood osmolarity decreased","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=29)"},{"llr":26.306,"date":"","count":8,"signal":"Selective eating disorder","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=26)"},{"llr":25.165,"date":"","count":13,"signal":"Status epilepticus","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=25)"},{"llr":23.532,"date":"","count":12,"signal":"Right ventricular failure","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=24)"},{"llr":20.488,"date":"","count":5,"signal":"Twin pregnancy","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=20)"}],"commonSideEffects":[],"contraindications":["Allergic Reactions","Classical phenylketonuria","Constipation","Dehydration","End stage renal disease","Hb SS disease","Heart disease","Humoral hypercalcemia of malignancy","Hypercalcemia","Hypercalciuria","Hyperkalemia","Hyperparathyroidism","Kidney disease","Kidney stone","Metabolic acidosis","Myocardial infarction in recovery phase","Osteolysis","Poisoning by digitalis glycoside","Renal tubular acidosis","Sarcoidosis","Ventricular fibrillation"],"specialPopulations":{"Pregnancy":"PERIKABIVEN (R) should be given to pregnant woman only if clearly needed. Severe malnutrition in pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if pregnant womans nutritional requirements cannot be fulfilled by oral or enteral intake.","Geriatric use":"Clinical Studies of Aminosyn II have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.","Paediatric use":"Safety and effectiveness of solutions from flexible plastic containers in pediatric patients have not been well established. Clinical Studies of Aminosyn II have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. If required, adjust the volume of PERIKABIVEN (R) administered based on serum electrolyte levels and fluid balance.","Renal impairment":"Patients on dialysis or continuous renal replacement therapy may require additional protein supplementation to meet nutritional requirements. If required, adjust the volume of PERIKABIVEN (R) administered based on serum electrolyte levels and fluid balance."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ARGININE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:24:45.112627+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:24:50.556553+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:24:45.185364+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ARGININE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:24:50.936053+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:24:43.989519+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:24:43.989544+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200381/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:24:51.818282+00:00"}},"allNames":"r-gene 10","offLabel":[],"synonyms":["l-arginine","L-Arg","arginine","arginine hydrochloride","arginine HCl"],"timeline":[{"date":"1973-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PHARMACIA AND UPJOHN to Pharmacia And Upjohn"},{"date":"1973-02-28","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pharmacia And Upjohn)"},{"date":"2019-07-25","type":"positive","source":"DrugCentral","milestone":"EMA approval (Advanced Accelerator Applications)"},{"date":"2021-06-23","type":"positive","source":"DrugCentral","milestone":"PMDA approval (FUJIFILM TOYAMA CHEMICAL Co., Ltd.)"}],"aiSummary":"R-Gene 10 (arginine) is a small molecule drug developed by Pharmacia and Upjohn, targeting nitric oxide synthase, inducible. It is classified as an arginine hydrochloride and was FDA-approved in 1973 for diagnostic testing of growth hormone secretion and renal radiation exposure from lutetium (177Lu) oxodotreotide. The drug has a bioavailability of 68% but lacks generic manufacturers due to its off-patent status. R-Gene 10 works by increasing the levels of arginine in the body, which in turn stimulates the production of nitric oxide. This drug is no longer under patent protection.","brandName":"R-Gene 10","ecosystem":[{"indication":"Diagnostic Test for Growth Hormone Secretion","otherDrugs":[{"name":"sermorelin","slug":"sermorelin","company":""}],"globalPrevalence":null},{"indication":"Renal radiation exposure from Lutetium (177Lu) oxodotreotide","otherDrugs":[{"name":"lysine","slug":"lysine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Nitric oxide synthase, inducible","novelty":"Follow-on","targets":[{"gene":"NOS2","source":"DrugCentral","target":"Nitric oxide synthase, inducible","protein":"Nitric oxide synthase, inducible"},{"gene":"GPRC6A","source":"DrugCentral","target":"G-protein coupled receptor family C group 6 member A","protein":"G-protein coupled receptor family C group 6 member A"}],"modality":"Small Molecule","drugClass":"arginine hydrochloride","explanation":"","oneSentence":"","technicalDetail":"R-Gene 10 acts as a substrate for nitric oxide synthase, an enzyme responsible for converting arginine into citrulline and nitric oxide, thereby increasing nitric oxide production."},"commercial":{"launchDate":"1973","_launchSource":"DrugCentral (FDA 1973-02-28, PHARMACIA AND UPJOHN)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1549","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ARGININE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ARGININE","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"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T08:49:33.115481","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:24:54.032415+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"lysine","drugSlug":"lysine","fdaApproval":"","relationship":"same-class"}],"genericName":"arginine","indications":{"approved":[{"name":"Diagnostic Test for Growth Hormone Secretion","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No eligibility criteria mentioned"},{"name":"Renal radiation exposure from Lutetium (177Lu) oxodotreotide","source":"DrugCentral","snomedId":218190002,"regulator":"FDA","eligibility":"No eligibility criteria mentioned"}],"offLabel":[],"pipeline":[]},"currentOwner":"Pharmacia And Upjohn","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"lysine","brandName":"lysine","genericName":"lysine","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04569591","phase":"NA","title":"DDAVP for Pituitary Adenoma","status":"RECRUITING","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","startDate":"2026-03-09","conditions":["Cushing's Disease","Pituitary Adenoma"],"enrollment":22,"completionDate":"2028-02-26"},{"nctId":"NCT04040634","phase":"NA","title":"Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hospital Israelita Albert Einstein","startDate":"2019-08-08","conditions":["Diabetes Mellitus","High Blood Pressure","Cardiovascular Diseases","Cognitive Impairment"],"enrollment":9476,"completionDate":"2026-05-31"},{"nctId":"NCT06883422","phase":"NA","title":"Pre-Surgical Immunonutrition's Effect on Colorectal 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Failure"],"enrollment":101,"completionDate":"2026-03-09"},{"nctId":"NCT06337838","phase":"PHASE3","title":"Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial","status":"RECRUITING","sponsor":"Hamilton Health Sciences Corporation","startDate":"2025-06-09","conditions":["Chronic Kidney Diseases","Acute Kidney Injury","Bleeding","Surgery"],"enrollment":100,"completionDate":"2027-06"},{"nctId":"NCT07393360","phase":"NA","title":"Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment","status":"RECRUITING","sponsor":"Pharmanutra S.p.a.","startDate":"2025-12-11","conditions":["Obesity & Overweight"],"enrollment":144,"completionDate":"2026-12"},{"nctId":"NCT06085729","phase":"PHASE1,PHASE2","title":"Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)","status":"SUSPENDED","sponsor":"M.D. Anderson Cancer Center","startDate":"2024-02-29","conditions":["Prostate Cancer"],"enrollment":30,"completionDate":"2027-12-31"},{"nctId":"NCT04278768","phase":"PHASE1,PHASE2","title":"Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)","status":"SUSPENDED","sponsor":"Curis, Inc.","startDate":"2020-07-06","conditions":["Acute Myelogenous Leukemia","Myelodysplastic Syndrome"],"enrollment":366,"completionDate":"2026-04-01"},{"nctId":"NCT06960148","phase":"PHASE3","title":"Dentinal Hypersensitivity Reduction Efficacy Study","status":"COMPLETED","sponsor":"Colgate Palmolive","startDate":"2025-03-04","conditions":["Sensitivity, Tooth"],"enrollment":95,"completionDate":"2025-05-13"},{"nctId":"NCT05813327","phase":"PHASE1","title":"Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Washington University School of 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Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough","status":"RECRUITING","sponsor":"Nocion Therapeutics","startDate":"2024-09-24","conditions":["Refractory or Unexplained Chronic Cough"],"enrollment":455,"completionDate":"2026-04-10"},{"nctId":"NCT07276152","phase":"NA","title":"Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology","status":"RECRUITING","sponsor":"University Hospital, Basel, Switzerland","startDate":"2026-01-09","conditions":["Sonic Augmentation Technology"],"enrollment":22,"completionDate":"2026-08"},{"nctId":"NCT05498428","phase":"PHASE2","title":"A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2022-11-11","conditions":["Carcinoma, Non-small-Cell Lung"],"enrollment":520,"completionDate":"2028-08-18"},{"nctId":"NCT04711135","phase":"PHASE2","title":"Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs","status":"ACTIVE_NOT_RECRUITING","sponsor":"Advanced Accelerator Applications","startDate":"2022-08-31","conditions":["Gastroenteropancreatic Neuroendocrine Tumors","Pheochromocytoma","Paraganglioma"],"enrollment":11,"completionDate":"2034-02-06"},{"nctId":"NCT07167693","phase":"PHASE1,PHASE2","title":"Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes","status":"RECRUITING","sponsor":"David K Carroll","startDate":"2025-12-19","conditions":["Diabetes (DM)","Diabetic Ketoacidosis","Ketosis Prone Diabetes","Hyperglycaemia (Diabetic)"],"enrollment":60,"completionDate":"2027-12-31"},{"nctId":"NCT06365047","phase":"PHASE3","title":"Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine","status":"ACTIVE_NOT_RECRUITING","sponsor":"Tufts University","startDate":"2024-08-31","conditions":["Xerostomia"],"enrollment":70,"completionDate":"2028-06-01"},{"nctId":"NCT07134231","phase":"PHASE3","title":"Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model","status":"COMPLETED","sponsor":"Colgate Palmolive","startDate":"2025-10-09","conditions":["Demineralization","Remineralization","Dental Cavity","Enamel Lesions"],"enrollment":36,"completionDate":"2025-12-11"},{"nctId":"NCT07394270","phase":"PHASE2","title":"Effect of Add-on L-Arginine Therapy on Heart Failure Patients","status":"NOT_YET_RECRUITING","sponsor":"German University in Cairo","startDate":"2026-02","conditions":["Heart Failure"],"enrollment":200,"completionDate":"2027-07"},{"nctId":"NCT06344442","phase":"PHASE3","title":"Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR 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