Benzoyl Peroxide

Benzoyl Peroxide is an FDA-registered drug product whose active ingredient is BENZOYL PEROXIDE. It is labelled by Malezia LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 77924-002, application M006, label effective 20260811. It is one of 56 FDA drug label records sharing the active ingredient BENZOYL PEROXIDE. 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 BENZOYL PEROXIDE are most often described in connection with: ndc indications. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

50 mL NDC: 77924-002-01 indications and usage

50 mL NDC: 77924-002-01 dosage and adminstration

50 mL NDC: 77924-002-01 Warning section

FDA lists 56 drug label records with BENZOYL PEROXIDE 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Benzoyl Peroxide used for?
50 mL NDC: 77924-002-01 indications and usage

Who makes Benzoyl Peroxide?
Malezia LLC is the labeler of record for Benzoyl Peroxide. 56 FDA label records share the active ingredient BENZOYL PEROXIDE, 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 Benzoyl Peroxide 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 Benzoyl Peroxide 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 BENZOYL PEROXIDE?
Yes. 56 FDA drug label records list BENZOYL PEROXIDE 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 Benzoyl Peroxide been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.