Is methylene blue FDA-approved?

Yes, as specific products: ProvayBlue and generic methylene blue injections, given intravenously, are FDA-approved, by prescription, for the uses in their labels.

Checked 25 Oct 2026. The sources are below.

Methylene blue

Also: methylthioninium chloride, ProvayBlue, Proveblue

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
OralOther
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • ProvayBlue (methylene blue) injection

    Intravenous

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic methylene blue injection, from several manufacturers

    Intravenous

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each product above as "Prescription".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add methylene blue in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.

  • Routes: every FDA-approved product above is an intravenous injection, and Drugs@FDA lists no oral methylene blue product. Peptimes offers oral and other routes (it records an intravenous dose as Other): choose the one that matches each dose. A compounded or other unapproved product doesn’t share an approved product’s approval.
  • Logging: the amount you took, the route and how you feel. Oral and other doses have no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell methylene blue or any other compound.

More sources

  • FDA, Drugs@FDA, checked 25 Oct 2026: product, route and marketing status for NDA 204630 (ProvayBlue) and generic injections such as ANDA 215636.
  • National Library of Medicine, DailyMed, checked 25 Oct 2026: the ProvayBlue label (section 11, description) and one generic’s methylene blue injection label.
  • FDA, Global Substance Registration System, Methylene blue, checked 25 Oct 2026: the names methylthioninium chloride and ProvayBlue.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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