{"id":"belladonna","rwe":[{"pmid":"41819152","year":"2026","title":"Toxic Risks of Nightshade Species: A comprehensive review of the documented toxicity of Atropa belladonna, Solanum dulcamara, and Solanum nigrum.","finding":"","journal":"Planta medica","studyType":"Clinical Study"},{"pmid":"41645580","year":"2026","title":"A Pull-Block Metabolic Engineering Strategy for High-Yield and High-Purity Hyoscyamine Production in Atropa belladonna.","finding":"","journal":"Biotechnology journal","studyType":"Clinical Study"},{"pmid":"41586387","year":"2026","title":"Potential Effect of Belladonna in the Management of Convulsions in Zebrafish (Danio rerio) and In Silico Mechanistic Approach.","finding":"","journal":"Annals of neurosciences","studyType":"Clinical Study"},{"pmid":"41572148","year":"2026","title":"Targeting the sirtuin 6-NF-κB p65 axis by 6-hydroxyhyoscyamine hydrobromide: a deacetylation-driven new therapy for diabetic wounds.","finding":"","journal":"Cellular & molecular biology letters","studyType":"Clinical Study"},{"pmid":"41550397","year":"2026","title":"A Case of Belladonna Poisoning With Late-Onset Reappearance of Anticholinergic Toxicity.","finding":"","journal":"Clinical case reports","studyType":"Clinical Study"}],"_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":"Small Molecule","category":"modality"},{"label":"Auricular (Otic)","category":"route"},{"label":"Active","category":"status"},{"label":"common pain or itching from swimmer’s ear","category":"indication"},{"label":"clogged ears","category":"indication"},{"label":"ear pain or itching from other earaches","category":"indication"},{"label":"Hyland's Inc.","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"674 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"543 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"540 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"469 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"465 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"431 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"429 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"392 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"347 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"328 reports"}]},"trials":[],"aliases":[],"company":"Hyland's Inc.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BELLADONNA","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:23:42.166825+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:24:45.247632+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:23:57.742174+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BELLADONNA","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:24:02.927702+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:23:40.917074+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:24:40.354486+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:23:40.917104+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":"2026-04-20T00:24:04.521225+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108906/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:24:03.706485+00:00"}},"allNames":"hylands naturals earache drops","offLabel":[],"synonyms":["Hylands Naturals Earache Drops","BELLADONNA LEAF"],"timeline":[],"aiSummary":"Hylands Naturals Earache Drops, containing belladonna, are currently marketed for the treatment of swimmer's ear pain or itching. The product leverages its unique mechanism of action, which is believed to reduce inflammation and pain, as a key competitive advantage. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition.","approvals":[],"brandName":"Hylands Naturals Earache Drops","ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Belladonna, a tropane alkaloid, is thought to exert its effects through its action on the nervous system, specifically by inhibiting the release of acetylcholine, a neurotransmitter involved in pain transmission."},"commercial":{},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"BELLADONNA\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA 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