Drugplain

EARACHE DROPS 30 [hp_C]/mL

belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur · LIQUID · Hyland's Inc.

4 Recalls on Record
Plain English

EARACHE DROPS is a liquid containing belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur at 30 [hp_C]/mL, taken auricular (otic). Manufactured by Hyland's Inc..

Key Facts

Brand Name
EARACHE DROPS
Generic Name
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur
NDC Code (Product)
54973-3172
Manufacturer
Hyland's Inc.
Strength
30 [hp_C]/mL
Dosage Form
LIQUID
Route
AURICULAR (OTIC)
Marketing Status
Marketing Start
06/17/2004

Recall History

4 Recalls on Record
Class II05/24/2022

Grato Holdings, Inc.

Microbial contamination of non-sterile product.

TerminatedVoluntary: Firm initiated
Class II04/15/2025

Pharmadel, LLC

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II06/05/2023

Homeocare Laboratories, Inc.

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II05/24/2022

Grato Holdings, Inc.

Microbial contamination of non-sterile product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

ear discomfort1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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

Dosage & 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.

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.

Frequently Asked Questions

What is EARACHE DROPS used for?

EARACHE DROPS contains belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur. It is a liquid taken auricular (otic). Consult your doctor for specific uses.

Is EARACHE DROPS a controlled substance?

EARACHE DROPS is not classified as a controlled substance by the DEA.

What is the generic name for EARACHE DROPS?

The generic name for EARACHE DROPS is belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur. There are 1 other brand versions of belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur.

What is the NDC code for EARACHE DROPS 30 [hp_C]/mL?

The NDC (National Drug Code) for EARACHE DROPS 30 [hp_C]/mL is 54973-3172, listed by Hyland's Inc..

Product NDC

54973-3172

Package NDC

54973-3172-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)