Is glutathione FDA-approved?

Not in the US. Glutathione isn't FDA-approved, and Drugs@FDA lists no application with it as an active ingredient.

Checked 25 Oct 2026. The sources are below, with the non-US regulator in More sources.

Glutathione

Also: GSH, L-glutathione, reduced glutathione, gamma-L-glutamyl-L-cysteinylglycine

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
SubcutaneousIntramuscularOralNasalOther
Updated
25 Oct 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with glutathione as an active ingredient. It lists glutathione disulfide only as one ingredient of irrigation solutions such as BSS PLUS; that approval covers that one product only.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add glutathione 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 “Approved outside the US”. In the US it is not FDA-approved.

  • Routes: subcutaneous, intramuscular, oral, nasal or Other. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous and intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Oral, nasal and Other doses skip this step.
  • 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 glutathione or any other compound.

More sources

  • FDA, Global Substance Registration System, Glutathione, checked 25 Oct 2026: the tripeptide structure and the names L-glutathione, reduced L-glutathione and gamma-Glu-Cys-Gly.
  • FDA, Drugs@FDA, NDA 018469, checked 25 Oct 2026: glutathione disulfide listed as one of the product’s eight active ingredients.
  • Italian Medicines Agency (AIFA), medicines database, search “glutatione”, checked 25 Oct 2026: glutathione sodium products for intramuscular or intravenous injection authorized in Italy, prescription only.

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