{"id":"selenium","rwe":[],"_fda":{"id":"7e58d660-4903-5cab-e053-2a91aa0ac70f","set_id":"00b62179-e03b-4972-902d-3a0c969b59bc","openfda":{"nui":["N0000185372","N0000175629","N0000184306","N0000185001","M0008890","M0000728"],"upc":["0361727319210"],"unii":["947UNF3Z6O","4QQN74LH4O","E4GA8884NN","H6241UJ22B","ETJ7Z6XBU4","AD84R52XLF","4K7Z7K7SWG"],"route":["SUBLINGUAL"],"spl_id":["7e58d660-4903-5cab-e053-2a91aa0ac70f"],"brand_name":["Hair-X Hair Loss Relief"],"spl_set_id":["00b62179-e03b-4972-902d-3a0c969b59bc"],"package_ndc":["61727-319-21"],"product_ndc":["61727-319"],"generic_name":["CADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDIS"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Fungal Proteins [CS]","Allergens [CS]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"substance_name":["CADMIUM SULFATE","GRAPHITE","PHOSPHORIC ACID","SELENIUM","SILICON DIOXIDE","THALLIUM","USTILAGO MAYDIS"],"pharm_class_epc":["Non-Standardized Fungal Allergenic Extract [EPC]"],"manufacturer_name":["Homeocare Laboratories"],"is_original_packager":[true]},"purpose":["Purpose: Hair loss-Alopecia."],"version":"2","warnings":["Warnings: If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Keep out of reach of children. Do not use if cap seal is broken or missing."],"effective_time":"20181231","active_ingredient":["Active Ingredients: Cadmium sulph. 12C, Graphites 4C, Phosphoricum acidum 5C, Silicea 4C, Selenium 5C, Thallium met. 7C, Ustilago 9C."],"inactive_ingredient":["Inactive Ingredients: Sucrose/lactose."],"indications_and_usage":["Indications & Usage: Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."],"dosage_and_administration":["Dosage & Administration: Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers."],"spl_product_data_elements":["Hair-X Hair Loss Relief CADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDIS SUCROSE LACTOSE CADMIUM SULFATE CADMIUM CATION GRAPHITE GRAPHITE PHOSPHORIC ACID PHOSPHORIC ACID SILICON DIOXIDE SILICON DIOXIDE SELENIUM SELENIUM THALLIUM THALLIUM USTILAGO MAYDIS USTILAGO MAYDIS"],"keep_out_of_reach_of_children":["Keep out of reach of children. Keep out of reach of children."],"package_label_principal_display_panel":["Hair-X Hair Loss Relief Hair-X Hair Loss Relief Homeopathic Medicine 85 Pellets hcl_label_hairx 2012.jpg hair-x hair loss relief"]},"tags":[{"label":"Non-Standardized Fungal Allergenic Extract [EPC]","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sublingual","category":"route"},{"label":"Lotion/Shampoo","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Chattem","category":"company"},{"label":"Approved 1990s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"940 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"689 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"666 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"655 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"625 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"604 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"552 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"517 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"430 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"423 reports"}]},"trials":[],"aliases":[],"company":"Chattem","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SELENIUM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:09:16.540947+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Selenium","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:09:23.831615+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:09:42.015716+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:09:22.423382+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:09:15.659570+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SELENIUM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:09:22.777821+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":"2026-04-20T01:09:15.062568+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:09:15.062598+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:09:31.667297+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:09:15.062605+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":"2026-04-20T01:09:24.269736+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200680/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:09:23.484884+00:00"}},"allNames":"hair-x hair loss relief","offLabel":[],"synonyms":["Hair-X Hair Loss Relief","CADMIUM SULFATE"],"timeline":[{"date":"1997-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from Padagis Us to Chattem"},{"date":"19970128","type":"positive","source":"OpenFDA","milestone":"FDA approval (Padagis Us)"}],"aiSummary":"SELENIUM (Hair-X Hair Loss Relief) is a marketed product by Chattem designed to stimulate hair growth, though its exact mechanism remains unknown. The key composition patent is set to expire in 2028, providing a clear timeline for potential generic competition. The primary risk lies in the lack of specified primary indication and key trial results, which may limit its market differentiation and regulatory support.","approvals":[{"date":"19970128","orphan":false,"company":"PADAGIS US","regulator":"FDA"}],"brandName":"Hair-X Hair Loss Relief","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"Non-Standardized Fungal Allergenic Extract [EPC]","explanation":"","oneSentence":"","technicalDetail":"As a non-standardized fungal allergenic extract, Hair-X Hair Loss Relief likely works by modulating the immune response, potentially through the activation of T-cells or the release of cytokines that promote hair growth."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Selenium","title":"Selenium","extract":"Selenium is a chemical element; it has symbol Se and atomic number 34. It has various physical appearances, including a brick-red powder, a vitreous black solid, and a grey metallic-looking form. It seldom occurs in this elemental state or as pure ore compounds in Earth's crust. Selenium was discovered in 1817 by Jöns Jacob Berzelius, who noted the similarity of the new element to the previously discovered tellurium.","wiki_history":"==History==\nthumb|upright|Selenium is named after [[Selene, the Greek Goddess of the Moon]]\nSelenium (Greek σελήνη selene meaning \"Moon\") was discovered in 1817 by Jöns Jacob Berzelius and Johan Gottlieb Gahn. Both chemists owned a chemistry plant near Gripsholm, Sweden, producing sulfuric acid by the lead chamber process. Pyrite samples from the Falun Mine produced a red solid precipitate in the lead chambers, which was presumed to be an arsenic compound, so the use of pyrite to make acid was discontinued. Berzelius and Gahn, who wanted to use the pyrite, observed that the red precipitate gave off an odor like horseradish when burned. This smell was not typical of arsenic, but a similar odor was known from tellurium compounds. Hence, Berzelius's first letter to Alexander Marcet stated that this was a tellurium compound. However, the lack of tellurium compounds in the Falun Mine minerals eventually led Berzelius to reanalyze the red precipitate, and in 1818 he wrote a second letter to Marcet describing a newly found element similar to sulfur and tellurium. Because of its similarity to tellurium, named for the Earth, Berzelius named the new element after the Moon.\n\nIn 1873, Willoughby Smith found that the electrical conductivity of grey selenium was affected by light. This led to its use as a cell for sensing light. The first commercial products using selenium were developed by Werner Siemens in the mid-1870s. The selenium cell was used in the photophone developed by Alexander Graham Bell in 1879. Selenium transmits an electric current proportional to the amount of light falling on its surface. This phenomenon was used in the design of light meters and similar devices. Selenium's semiconductor properties found numerous other applications in electronics. The development of selenium rectifiers began during the early 1930s, and these replaced copper oxide rectifiers because they were more efficient. These lasted in commercial applications until the 1970s, following whic"},"commercial":{"launchDate":"1997","_launchSource":"OpenFDA (19970128, PADAGIS US)"},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"SELENIUM\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:\"SELENIUM\"","fields":["approvals","company"],"source":"OpenFDA Drugs@FDA"},{"id":3,"url":"https://clinicaltrials.gov/search?intr=selenium","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":4,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=selenium","fields":["publications"],"source":"PubMed/NCBI"},{"id":5,"url":"https://en.wikipedia.org/wiki/Selenium","fields":["history","overview"],"source":"Wikipedia"},{"id":6,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-31T10:24:43.705188","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T01:09:42.015807+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"selenium","indications":{"approved":[{"id":"selenium-not-specified","name":"Not Specified","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not Specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not Specified","diagnosticRequired":null,"brandNameForIndication":"Hair-X Hair Loss Relief"}],"offLabel":[],"pipeline":[]},"currentOwner":"Chattem","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT07427017","phase":"PHASE2","title":"Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies","status":"RECRUITING","sponsor":"Northwestern University","startDate":"2026-02","conditions":["Ulcerative Colitis (UC)"],"enrollment":180,"completionDate":"2028-12"},{"nctId":"NCT07462858","phase":"NA","title":"Tuna Based Nuggets and Ischemic Cardiomyopathy","status":"COMPLETED","sponsor":"University of Lahore Hospital (ULH)","startDate":"2025-09-15","conditions":["Ischemic Cardiomyopathy","Obesity, Metabolically Benign"],"enrollment":120,"completionDate":"2026-01-25"},{"nctId":"NCT06979180","phase":"NA","title":"A Clinical Trial to Investigate 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