{"id":"sulfur","rwe":[],"_fda":{"id":"3d61c82d-1702-01d5-e063-6394a90a5aa4","set_id":"017ed754-9fe8-2cb5-e063-6294a90ab2f6","openfda":{"unii":["6GZW20TIOI","H0G9379FGK","FGL3685T2X","C88X29Y479","4M1169RWJD","70FD1KFU70"],"route":["AURICULAR (OTIC)"],"spl_id":["3d61c82d-1702-01d5-e063-6394a90a5aa4"],"brand_name":["Hylands Naturals Earache Drops"],"spl_set_id":["017ed754-9fe8-2cb5-e063-6294a90ab2f6"],"package_ndc":["54973-4124-1"],"product_ndc":["54973-4124"],"generic_name":["BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BELLADONNA LEAF","CALCIUM CARBONATE","CHAMOMILE","LYCOPODIUM CLAVATUM SPORE","PULSATILLA PATENS WHOLE","SULFUR"],"manufacturer_name":["Hyland's Inc."],"is_original_packager":[true]},"purpose":["Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician"],"version":"5","warnings":["Warnings Keep away from eyes. Do not use if you have ear tubes, damaged ear drums or after ear surgery. Stop use and ask a doctor if: ■ symptoms persist for more than 48 hours or worsen. ■ any discharge from ear is present. ■ symptoms are accompanied by a fever. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children."],"questions":["Questions? www.hylands.com or care@hylands.com"],"ask_doctor":["Stop use and ask a doctor if: ■ symptoms persist for more than 48 hours or worsen. ■ any discharge from ear is present. ■ symptoms are accompanied by a fever."],"do_not_use":["Do not use if you have ear tubes, damaged ear drums or after ear surgery."],"effective_time":"20250827","active_ingredient":["Active ingredients Purpose* Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) ear pain Calcarea Carbonica 30C HPUS ear pain, sensitivity to cold Chamomilla 30C HPUS ear pain, sensitivity to drafts, plugged ears Lycopodium 30C HPUS ear pain Pulsatilla 30C HPUS ear itching Sulphur 30C HPUS ear pain with burning, sensitivity to water HPUS\" is the Homeopathic Pharmacopoeia of the United States."],"inactive_ingredient":["Inactive ingredients Citric Acid, Glycerine, Purified Water."],"indications_and_usage":["Uses* Temporarily relieves: ■ common pain or itching from swimmer’s ear ■ clogged ears ■ ear pain or itching from other earaches, after diagnosis by a physician"],"active_ingredient_table":["
Active ingredientsPurpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)ear pain
Calcarea Carbonica 30C HPUSear pain, sensitivity to cold
Chamomilla 30C HPUSear pain, sensitivity to drafts, plugged ears
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching
Sulphur 30C HPUSear pain with burning, sensitivity to water
"],"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"spl_unclassified_section":["Drug Facts Active ingredients Purpose* Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) ear pain Calcarea Carbonica 30C HPUS ear pain, sensitivity to cold Chamomilla 30C HPUS ear pain, sensitivity to drafts, plugged ears Lycopodium 30C HPUS ear pain Pulsatilla 30C HPUS ear itching Sulphur 30C HPUS ear pain with burning, sensitivity to water HPUS\" is the Homeopathic Pharmacopoeia of the United States.","Drug Facts (continued) Directions Adults and children ages 4 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"dosage_and_administration":["Directions Adults and children ages 4 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using."],"spl_product_data_elements":["Hylands Naturals Earache Drops belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur CHAMOMILE CHAMOMILE LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE PULSATILLA PATENS WHOLE PULSATILLA PATENS WHOLE GLYCERIN SULFUR SULFUR CALCIUM CARBONATE CALCIUM CATION BELLADONNA LEAF BELLADONNA LEAF WATER CITRIC ACID MONOHYDRATE"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"spl_unclassified_section_table":["
Active ingredientsPurpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)ear pain
Calcarea Carbonica 30C HPUSear pain, sensitivity to cold
Chamomilla 30C HPUSear pain, sensitivity to drafts, plugged ears
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching
Sulphur 30C HPUSear pain with burning, sensitivity to water
"],"package_label_principal_display_panel":["Principal Display Panel Hyland's Earache Drops 0.33 FL. OZ. (10 mL) EARS000L0.33CTNH2"]},"tags":[{"label":"sulfur","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Carbonic anhydrase 1","category":"target"},{"label":"CA1","category":"gene"},{"label":"CA2","category":"gene"},{"label":"D10AB02","category":"atc"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cloth","category":"form"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Acne vulgaris","category":"indication"},{"label":"Acneiform eruption","category":"indication"},{"label":"Acute necrotizing ulcerative gingivitis","category":"indication"},{"label":"Aphthous ulcer of mouth","category":"indication"},{"label":"Greasy skin","category":"indication"},{"label":"Pityriasis simplex","category":"indication"},{"label":"Poythress","category":"company"},{"label":"Approved 1940s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":96.635,"date":"","count":179,"signal":"Drug hypersensitivity","source":"DrugCentral FAERS","actionTaken":"Reported 179 times (LLR=97)"},{"llr":72.317,"date":"","count":14,"signal":"Broncholithiasis","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=72)"},{"llr":61.443,"date":"","count":14,"signal":"Lymph node calcification","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=61)"},{"llr":56.066,"date":"","count":16,"signal":"Choroiditis","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=56)"},{"llr":48.226,"date":"","count":23,"signal":"Exposure to toxic agent","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=48)"},{"llr":43.671,"date":"","count":8,"signal":"Lichen nitidus","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=44)"},{"llr":41.426,"date":"","count":32,"signal":"Oesophagitis","source":"DrugCentral FAERS","actionTaken":"Reported 32 times (LLR=41)"},{"llr":36.445,"date":"","count":14,"signal":"Bronchial wall thickening","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=36)"},{"llr":35.193,"date":"","count":87,"signal":"Completed suicide","source":"DrugCentral FAERS","actionTaken":"Reported 87 times (LLR=35)"},{"llr":34.667,"date":"","count":11,"signal":"Lower respiratory tract infection viral","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=35)"},{"llr":33.671,"date":"","count":18,"signal":"Endophthalmitis","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=34)"},{"llr":31.235,"date":"","count":68,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 68 times (LLR=31)"},{"llr":30.888,"date":"","count":128,"signal":"Toxicity to various agents","source":"DrugCentral FAERS","actionTaken":"Reported 128 times (LLR=31)"},{"llr":29.843,"date":"","count":30,"signal":"Visual acuity reduced","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=30)"},{"llr":28.231,"date":"","count":9,"signal":"Soft tissue necrosis","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=28)"}],"commonSideEffects":[{"effect":"Irritation","drugRate":"","severity":"uncommon","organSystem":""},{"effect":"Hypersensitivity","drugRate":"","severity":"uncommon","organSystem":""}],"contraindications":["Adrenal cortical hypofunction","Anemia due to enzyme deficiency","Atrophoderma","Blister","Conduction disorder of the heart","Condyloma acuminatum","Decreased respiratory function","Deficiency of glucose-6-phosphate dehydrogenase","Denuded skin","Diabetes mellitus","Eruption of skin","Erythroderma","Infection of skin AND/OR subcutaneous tissue","Inflammatory dermatosis","Kidney disease","Open wound","Peripheral vascular disease","Seizure disorder","Skin irritation","Telangiectasia disorder"],"seriousAdverseEvents":[{"effect":"Stevens-Johnson syndrome","drugRate":"","severity":"serious"},{"effect":"Local hypersensitivity progressing to systemic lupus erythematosus-like syndrome","drugRate":"","severity":"serious"},{"effect":"Fatal outcome","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Poythress","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SULFUR","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:04:45.373233+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:04:51.188998+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SULFUR","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:04:51.669222+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:44.262550+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:44.262591+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1235452/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:04:52.406562+00:00"}},"allNames":["sulfur"],"offLabel":[],"synonyms":["sulfur"],"timeline":[{"date":"1940-09-17","type":"positive","source":"DrugCentral","milestone":"FDA approval (Poythress)"}],"approvals":[{"date":"1940-09-17","orphan":false,"company":"POYTHRESS","regulator":"FDA"}],"ecosystem":[{"indication":"Acne vulgaris","otherDrugs":[{"name":"adapalene","slug":"adapalene","company":"Galderma Labs Lp"},{"name":"ammonia","slug":"ammonia","company":""},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"azelaic acid","slug":"azelaic-acid","company":"Allergan"}],"globalPrevalence":null},{"indication":"Acneiform eruption","otherDrugs":[{"name":"resorcinol","slug":"resorcinol","company":""}],"globalPrevalence":null},{"indication":"Acute necrotizing ulcerative gingivitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Aphthous ulcer of mouth","otherDrugs":[{"name":"amlexanox","slug":"amlexanox","company":"Uluru"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"},{"name":"triamcinolone","slug":"triamcinolone","company":""}],"globalPrevalence":null},{"indication":"Greasy skin","otherDrugs":[],"globalPrevalence":null},{"indication":"Pityriasis simplex","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonia","slug":"ammonia","company":""},{"name":"carbamide","slug":"carbamide","company":"Hospira"},{"name":"chloroxine","slug":"chloroxine","company":""}],"globalPrevalence":null},{"indication":"Seborrheic dermatitis","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"allantoin","slug":"allantoin","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonia","slug":"ammonia","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Carbonic anhydrase 1","novelty":"First-in-class","targets":[{"gene":"CA1","source":"DrugCentral","target":"Carbonic anhydrase 1","protein":"Carbonic anhydrase 1"},{"gene":"CA2","source":"DrugCentral","target":"Carbonic anhydrase 2","protein":"Carbonic anhydrase 2"}],"modality":"Small Molecule","drugClass":"sulfur","explanation":"","oneSentence":"","technicalDetail":"SULFUR's mechanism of action involves competitive inhibition of carbonic anhydrase 1, a zinc-dependent enzyme that catalyzes the reversible hydration of carbon dioxide to bicarbonate and protons, thereby influencing skin pH and oil production."},"commercial":{"launchDate":"1940","_launchSource":"DrugCentral (FDA 1940-09-17, POYTHRESS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4260","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SULFUR","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SULFUR","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":"2026-03-30T15:46:27.103158","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:04:54.990409+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"acetazolamide","drugSlug":"acetazolamide","fdaApproval":"1953-07-27","genericCount":29,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"acetohydroxamic acid","drugSlug":"acetohydroxamic-acid","fdaApproval":"1983-05-31","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"bendroflumethiazide","drugSlug":"bendroflumethiazide","fdaApproval":"1959-12-07","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"benzthiazide","drugSlug":"benzthiazide","fdaApproval":"1960-10-14","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"bortezomib","drugSlug":"bortezomib","fdaApproval":"2003-05-13","patentExpiry":"Sep 23, 2042","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"brinzolamide","drugSlug":"brinzolamide","fdaApproval":"1998-04-01","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"cefuroxime","drugSlug":"cefuroxime","fdaApproval":"1983-10-19","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"celecoxib","drugSlug":"celecoxib","fdaApproval":"1998-12-31","patentExpiry":"May 27, 2036","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"chlorothiazide","drugSlug":"chlorothiazide","fdaApproval":"1958-09-04","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"chlortalidone","drugSlug":"chlortalidone","fdaApproval":"1960-04-07","relationship":"same-target"}],"genericName":"sulfur","indications":{"approved":[{"name":"Acne vulgaris","source":"DrugCentral","snomedId":88616000,"regulator":"FDA","eligibility":"Adults and children 12 years and older. Apply only to areas with acne."},{"name":"Acneiform eruption","source":"DrugCentral","snomedId":402644006,"regulator":"FDA","eligibility":"Adults and children 12 years and older. Apply only to areas with acne."},{"name":"Acute necrotizing ulcerative gingivitis","source":"DrugCentral","snomedId":399050001,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned."},{"name":"Aphthous ulcer of mouth","source":"DrugCentral","snomedId":426965005,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned."},{"name":"Greasy skin","source":"DrugCentral","snomedId":42273000,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned."},{"name":"Pityriasis simplex","source":"DrugCentral","snomedId":200767005,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned."},{"name":"Seborrheic dermatitis","source":"DrugCentral","snomedId":50563003,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned."}],"offLabel":[{"name":"Itching of skin","source":"DrugCentral","drugName":"SULFUR"},{"name":"Rosacea","source":"DrugCentral","drugName":"SULFUR"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"acetazolamide","brandName":"acetazolamide","genericName":"acetazolamide","approvalYear":"1953","relationship":"same-target"},{"drugId":"acetohydroxamic-acid","brandName":"acetohydroxamic acid","genericName":"acetohydroxamic 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