LidexaGel 5%

LidexaGel 5% is an FDA-registered drug product whose active ingredient is LIDOCAINE HCL. It is labelled by Oncora Pharma, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 85477-730, label effective 20260708. It is one of 11 FDA drug label records sharing the active ingredient LIDOCAINE HCL. 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 HCL are most often described in connection with: temporary relief. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS: For the temporary relief of pain.

DOSAGE: Adults and children 12 years of age and older: apply a thin film to the affected areas(s) two or three times per day or as directed by a licensed healthcare practitioner.

CONTRAINDICATIONS: Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

ADVERSE REACTIONS: During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

FDA lists 11 drug label records with LIDOCAINE HCL 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 LidexaGel 5% used for?
INDICATIONS: For the temporary relief of pain.

Who makes LidexaGel 5%?
Oncora Pharma, LLC is the labeler of record for LidexaGel 5%. 11 FDA label records share the active ingredient LIDOCAINE HCL, 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 LidexaGel 5% come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is LidexaGel 5% prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LIDOCAINE HCL?
Yes. 11 FDA drug label records list LIDOCAINE HCL 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 LidexaGel 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.