Is DHEA FDA-approved?

No. It's sold as a dietary supplement, and FDA doesn't approve supplements. The same substance, prasterone, is approved in one product only: Intrarosa, a prescription vaginal insert.

Checked 25 Oct 2026. The sources are below.

DHEA

Also: dehydroepiandrosterone, prasterone, dehydroisoandrosterone, EM-760, Intrarosa

Status label in the Peptimes Library
Dietary Supplement
Routes in Peptimes
Oral
Updated
25 Oct 2026

US regulatory status

  • FDA status

    Not FDA-Approved as a dietary supplement. FDA does not approve dietary supplements for safety and effectiveness.

    Source: FDA, checked 25 Oct 2026

  • FDA status

    Prasterone, the same substance, is FDA-approved in one product: Intrarosa, a prescription vaginal insert, for the use in its label. That approval doesn't carry over to DHEA sold as a supplement.

    Source: DailyMed label, checked 25 Oct 2026

How to track it in Peptimes

Add DHEA 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 “Dietary Supplement”.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s 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 HRT tracker app page.

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

More sources

  • FDA, FDA 101: Dietary Supplements, checked 25 Oct 2026: FDA doesn’t approve dietary supplements for safety and effectiveness.
  • FDA, Drugs@FDA, NDA 208470 (Intrarosa), checked 25 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Prasterone, checked 25 Oct 2026: the names dehydroepiandrosterone, DHEA, dehydroisoandrosterone and EM-760.

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