EarBalance Ear Pain Drops

EarBalance Ear Pain Drops is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE OTIC SOLUTION. It is labelled by Marie's Original Formulas LLC taken by auricular (otic) and marketed as a human otc drug product. Identifiers on file: NDC 87541-644, application M014, label effective 20260722. It is one of 2 FDA drug label records sharing the active ingredient LIDOCAINE HYDROCHLORIDE OTIC SOLUTION. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LIDOCAINE HYDROCHLORIDE OTIC SOLUTION are most often described in connection with: temporarily relieves, ear discomfort, minor pain, canal irritation, post-irritation soreness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves ear discomfort and minor pain associated with swimmer's ear, ear canal irritation, and post-irritation soreness.

Directions Ages 6-12: 3-5 drops up to 4 times daily Ages 2-5: 2-3 drops up to 3 times daily Keep head tilted 2-3 minutes Do not use longer than 4 days unless directed by a doctor Under 2 years: ask a doctor

Warnings For use in the ear canal only.

FDA lists 2 drug label records with LIDOCAINE HYDROCHLORIDE OTIC SOLUTION as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is EarBalance Ear Pain Drops used for?
Uses Temporarily relieves ear discomfort and minor pain associated with swimmer's ear, ear canal irritation, and post-irritation soreness.

Who makes EarBalance Ear Pain Drops?
Marie's Original Formulas LLC is the labeler of record for EarBalance Ear Pain Drops. 2 FDA label records share the active ingredient LIDOCAINE HYDROCHLORIDE OTIC SOLUTION, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does EarBalance Ear Pain Drops come in?
administered by auricular (otic). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is EarBalance Ear Pain Drops prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LIDOCAINE HYDROCHLORIDE OTIC SOLUTION?
Yes. 2 FDA drug label records list LIDOCAINE HYDROCHLORIDE OTIC SOLUTION as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has EarBalance Ear Pain Drops been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.