Hy

OTC products · Product label record

Hylands Naturals Earache Drops drug information

BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR
Hyland's Inc. · AURICULAR (OTIC)

Product NDC: 54973-4124

Join the community
CommunityExperiencesReviewsDrug database
Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR
Labeler / manufacturerHyland's Inc.
RouteAURICULAR (OTIC)
Drug classDrug class not supplied in source label
Product NDC54973-4124
Label effective date2026-08-24

Official product label reference

Hylands Naturals Earache Drops — Hyland's Inc.

This page contains 13 source sections for BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR, auricular (otic) route. Label set 017ed754-9fe8-2cb5-e063-6294a90ab2f6, version 7.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

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
Dosage and administration — label text
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.
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.
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. Table text from source: | 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
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. Table text from source: | 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
Do not use
Do not use if you have ear tubes, damaged ear drums or after ear surgery.
Ask a doctor before use
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.
Child safety
Keep out of reach of children.
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.

Official sources and product identifiers

Substances listed: CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA PATENS WHOLE, SULFUR, CALCIUM CARBONATE, BELLADONNA LEAF

Package NDC codes

54973-4124-1

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.