Peptimes

Track progesterone in Peptimes

Progesterone (pregn-4-ene-3,20-dione) is a progestin, a steroid. It is the active ingredient in FDA-approved prescription capsules taken by mouth, vaginal gels and inserts, and injections in oil. (Source: DailyMed label.)

Is progesterone FDA-approved?

Yes, as specific products: progesterone capsules, Crinone vaginal gel, vaginal inserts and injection in oil are FDA-approved, by prescription, for the uses in their labels. No progesterone cream is FDA-approved.

Checked 25 Oct 2026. The sources are below.

Progesterone

Also: micronized progesterone, progesterone in oil, PIO, Prometrium, Utrogestan, Crinone, Endometrin

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
OralOtherIntramuscularTopical
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.

  • Prometrium (progesterone) capsules and generic progesterone capsules

    Oral

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Crinone 8% (progesterone) vaginal gel

    Vaginal

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Endometrin (progesterone) vaginal insert and generic inserts

    Vaginal

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Progesterone injection in oil (generic, from several manufacturers)

    Intramuscular

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Progesterone creams

    None approved

    Not FDA-Approved. Drugs@FDA lists no topical or transdermal progesterone product.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each FDA-approved 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

The Library has three progesterone entries. “Progesterone (oral)” and “Progesterone (vaginal/injection)” show the status label “FDA Approved”; “Progesterone (cream)” shows “Not FDA-Approved”. Add the entry that matches your own product 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. The list above gives the detail by product.

  • Routes by entry: “Progesterone (oral)” is oral; “Progesterone (vaginal/injection)” is logged as Other (vaginal) or intramuscular; “Progesterone (cream)” is topical. The topical route comes only from the cream entry, which the app labels “Not FDA-Approved”: no topical progesterone product is FDA-approved.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Oral, vaginal and topical 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 HRT tracker app page.

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

More sources

  • FDA, Drugs@FDA, checked 25 Oct 2026: product, route and marketing status for NDA 019781 (Prometrium), NDA 020701 (Crinone), NDA 022057 (Endometrin) and ANDA 075906 (a generic progesterone injection).
  • FDA, Global Substance Registration System, Progesterone, checked 25 Oct 2026: the names micronized progesterone and Utrogestan.

HRT tracker appInjection-site history in PeptimesWhat FDA status terms mean

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