Capsaicin 0.035

Capsaicin 0.035 is an FDA-registered drug product whose active ingredient is CAPSAICIN. It is labelled by Medcore LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82461-421, application 505G(a)(3), label effective 20260902. It is one of 24 FDA drug label records sharing the active ingredient CAPSAICIN. 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 CAPSAICIN 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.

Uses For temporary relief of pain

Directions Adult and children 12 years of age and over : clean and dry affected area apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age : consult a doctor

Warnings (For external use only)

FDA lists 24 drug label records with CAPSAICIN 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 Capsaicin 0.035 used for?
Uses For temporary relief of pain

Who makes Capsaicin 0.035?
Medcore LLC is the labeler of record for Capsaicin 0.035. 24 FDA label records share the active ingredient CAPSAICIN, 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 Capsaicin 0.035 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 Capsaicin 0.035 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 CAPSAICIN?
Yes. 24 FDA drug label records list CAPSAICIN 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 Capsaicin 0.035 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.