Lidocaine 5%

Lidocaine 5% is an FDA-registered drug product whose active ingredient is LIDOCAINE. It is labelled by Apnar Pharma LP taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 24689-124, application M015, label effective 20231021. It is one of 45 FDA drug label records sharing the active ingredient LIDOCAINE. 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 are most often described in connection with: usage adults, children years, older apply, affected area, times day, age consult. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USAGE Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor

DOSAGE 50 miligrams/gram per application

When using this product Avoid contact with eyes Do not exceed recommended dosage unless directed by a doctor

FDA lists 45 drug label records with LIDOCAINE 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 Lidocaine 5% used for?
USAGE Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor

Who makes Lidocaine 5%?
Apnar Pharma LP is the labeler of record for Lidocaine 5%. 45 FDA label records share the active ingredient LIDOCAINE, 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 Lidocaine 5% come in?
administered by rectal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lidocaine 5% 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?
Yes. 45 FDA drug label records list LIDOCAINE 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 Lidocaine 5% 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.