Is oxytocin FDA-approved?

Yes, as specific products: Pitocin and generic oxytocin injections are FDA-approved, by prescription, for the uses in their labels. The only nasal spray, Syntocinon, is discontinued.

Checked 25 Oct 2026. The sources are below.

Oxytocin

Also: Pitocin, Syntocinon

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

  • Pitocin (oxytocin) injection

    Intravenous infusion or intramuscular injection

    The uses in its label. For some of those uses, the label says it should be given "only by the intravenous route and with adequate medical supervision in a hospital".

    Source: DailyMed label, checked 25 Oct 2026

  • Generic oxytocin injection, from several manufacturers

    Intravenous infusion or intramuscular injection

    As stated on each product's label (approved through new drug applications and abbreviated new drug applications).

    Source: DailyMed label, checked 25 Oct 2026

  • Syntocinon (oxytocin) nasal spray

    Nasal

    Discontinued. Drugs@FDA lists Syntocinon nasal spray as "Discontinued" and lists no other nasal oxytocin product.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each marketed 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 oxytocin 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 and route.

  • Routes: in the US, oxytocin is an IV or IM injection given in hospital (Pitocin); no nasal product is marketed in the US. Peptimes offers intramuscular, nasal and other routes (it records an intravenous dose as Other): choose the one that matches each dose.
  • 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. 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 oxytocin or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 018261 (Pitocin), NDA 018243 and NDA 018248 (oxytocin injection) and NDA 012285 (Syntocinon nasal spray), checked 25 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Oxytocin, checked 25 Oct 2026: its sequence of nine amino acids, and the names Pitocin and Syntocinon.

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