Peptimes

Track minoxidil in Peptimes

Minoxidil is a small synthetic molecule, a piperidinyl pyrimidine derivative that its tablet label classes as a peripheral vasodilator. It is the active ingredient in prescription minoxidil tablets and in over-the-counter topical solutions and foams. (Source: DailyMed label.)

Is minoxidil FDA-approved?

Yes, as specific products: generic minoxidil tablets (prescription) and Rogaine and other minoxidil topical solutions and foams (over the counter) are FDA-approved for the uses in their labels.

Checked 25 Oct 2026. The sources are below.

Minoxidil

Also: Rogaine, Loniten, U-10858

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

  • Generic minoxidil tablets, from several manufacturers

    Oral

    Only for high blood pressure that is symptomatic or has caused organ damage and that other blood-pressure medicines haven't controlled, as the label defines (approved through abbreviated new drug applications, ANDAs).

    Source: DailyMed label, checked 25 Oct 2026

  • Loniten (minoxidil) tablets

    Oral

    Discontinued. Drugs@FDA lists Loniten as "Discontinued"; the generic tablets above remain.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Rogaine (minoxidil) topical solution, for men and for women

    Topical

    Over the counter, for the use in its Drug Facts label.

    Source: DailyMed label, checked 25 Oct 2026

  • Men's Rogaine Extra Strength (minoxidil) topical solution

    Topical

    Over the counter, for the use in its Drug Facts label, in men.

    Source: DailyMed label, checked 25 Oct 2026

  • Men's Rogaine and Women's Rogaine (minoxidil) topical foam

    Topical

    Over the counter, for the use in each Drug Facts label.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic and store-brand minoxidil topical solutions and foams, from several manufacturers

    Topical

    Over the counter, as stated on each product's Drug Facts label (approved through ANDAs).

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only for the tablets. The topical solutions and foams are sold over the counter: Drugs@FDA lists the tablets as "Prescription" and the topical products as "Over-the-counter".

    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 minoxidil 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, route and use.

  • Routes: topical and oral. Choose the one that matches each dose. In the US the tablets are prescription only and the topical products are sold over the counter.
  • Logging: the amount you took, the route and how you feel.
  • No injection sites: topical and oral doses never carry an injection site.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the finasteride, dutasteride and minoxidil tracker page.

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

More sources

  • FDA, Drugs@FDA: NDA 018154 (Loniten tablets), NDA 019501 (Rogaine solution, for men and for women), NDA 020834 (Rogaine Extra Strength solution) and NDA 021812 (Men’s and Women’s Rogaine foam), checked 25 Oct 2026: product, route and marketing status, and the related over-the-counter products listed with them.
  • FDA, Global Substance Registration System, Minoxidil, checked 25 Oct 2026: the names Loniten and Rogaine, and the code name U-10858.

Finasteride, dutasteride and minoxidil trackerWhat FDA status terms mean

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