Lidonex
Lidonex is an FDA drug label for the active ingredient LIDOCAINE HCL, MENTHOL manufactured by Aldama Pharmaceuticals, Inc administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260807.
- Generic name
- LIDOCAINE HCL, MENTHOL
- Manufacturer
- Aldama Pharmaceuticals, Inc
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 73564-804
- Application
- M017
- Label effective
- 20260807
About this product
Lidonex is an FDA-registered drug product whose active ingredient is LIDOCAINE HCL, MENTHOL. It is labelled by Aldama Pharmaceuticals, Inc taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 73564-804, application M017, label effective 20260807. It is one of 3 FDA drug label records sharing the active ingredient LIDOCAINE HCL, MENTHOL. 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.
What it is used for
Across FDA labelling, products containing LIDOCAINE HCL, MENTHOL are most often described in connection with: temporarily relief. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use For temporarily relief of pain
Dosage & Administration
Directions Adults and children over 12 years of age and over clean and dry affected area apply to affected area not more than 3 to 4 times daily Children under 12 years of age: Consult a doctor
Warnings
Warnings For external use only Flammable: Keep away from fire or flame Do not use on wounds or damaged skin in large quantaties with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed. avoid contact with the eyes, mucous membranes or rashes do not bandage tightly Stop use and ask doctor if skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days
More products with the same ingredient
LIDOCAINE HCL, MENTHOLHow products containing LIDOCAINE HCL, MENTHOL compare
FDA lists 3 drug label records with LIDOCAINE HCL, MENTHOL 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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | ASCLEMED USA INC. | 1 |
| — | — | Aldama Pharmaceuticals, Inc | 1 |
| — | — | Asclemed USA, Inc. | 1 |
| — | — | — | — |
| — | — | — | — |
Frequently asked questions
What is Lidonex used for?
Use For temporarily relief of pain
Who makes Lidonex?
Aldama Pharmaceuticals, Inc is the labeler of record for Lidonex. 3 FDA label records share the active ingredient LIDOCAINE HCL, MENTHOL, 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 Lidonex 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 Lidonex 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 HCL, MENTHOL?
Yes. 3 FDA drug label records list LIDOCAINE HCL, MENTHOL 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 Lidonex 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.