{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 80 } }, "results": [ { "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" ], "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." ], "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
" ], "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." ], "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
" ], "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" ], "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." ], "do_not_use": [ "Do not use if you have ear tubes, damaged ear drums or after ear surgery." ], "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." ], "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." ], "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." ], "inactive_ingredient": [ "Inactive ingredients Citric Acid, Glycerine, Purified Water." ], "questions": [ "Questions? www.hylands.com or care@hylands.com" ], "other_safety_information": [ "DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING." ], "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" ], "package_label_principal_display_panel": [ "Principal Display Panel Hyland's Earache Drops 0.33 FL. OZ. (10 mL) EARS000L0.33CTNH3" ], "set_id": "017ed754-9fe8-2cb5-e063-6294a90ab2f6", "id": "51cbd865-af45-eab9-e063-6394a90a8387", "effective_time": "20260514", "version": "6", "openfda": { "brand_name": [ "Hylands Naturals Earache Drops" ], "generic_name": [ "BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR" ], "manufacturer_name": [ "Hyland's Inc." ], "product_ndc": [ "54973-4124" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "AURICULAR (OTIC)" ], "substance_name": [ "BELLADONNA LEAF", "CALCIUM CARBONATE", "CHAMOMILE", "LYCOPODIUM CLAVATUM SPORE", "PULSATILLA PATENS WHOLE", "SULFUR" ], "spl_id": [ "51cbd865-af45-eab9-e063-6394a90a8387" ], "spl_set_id": [ "017ed754-9fe8-2cb5-e063-6294a90ab2f6" ], "package_ndc": [ "54973-4124-1" ], "is_original_packager": [ true ], "unii": [ "6GZW20TIOI", "H0G9379FGK", "FGL3685T2X", "C88X29Y479", "4M1169RWJD", "70FD1KFU70" ] } } ] }