First Over-the-Counter Erectile Dysfunction Gel Approved, Promising 10-Minute Results

For the first time, the FDA has approved an over-the-counter erectile dysfunction topical gel that delivers results in just 10 minutes. The approval marks a significant shift in accessibility, but experts warn of the need for consumer guidance and awareness of cardiovascular risks.

Key Points

The FDA has cleared a topical gel (Eroxon/MED3000) for erectile dysfunction that promises quick results, without needing a prescription.
Clinical trials report erection onset in approximately 10 minutes, faster than traditional oral medications.
Medical professionals caution that long-term safety, efficacy, and the risk of bypassing medical evaluation remain significant concerns.

Study at a Glance

Regulatory Decision & Date: FDA cleared the first OTC ED gel in June 2023. U.S. Food and Drug Administrationmedicaldevice-network.com
Product & Composition: The gel, marketed as Eroxon (MED3000), functions through volatile solvents producing cooling-then-warming effects to stimulate nitric oxide release.
Primary Outcomes: About 65–70% of clinical trial participants achieved erections within 10 minutes, with minimal side effects such as mild headache or nausea (1–4%).

What’s New vs Prior Evidence

Previously, all effective ED treatments in the U.S. required a prescription and involved oral medications, specifically PDE5 inhibitors like Viagra or Cialis, which take 30–60 minutes to act and have systemic side effects. The newly FDA-approved gel represents the first non-prescription, topical option that works much faster. It bypasses the digestive system and delivers a localized reaction, making it attractive for immediacy and discretion. However, while its efficacy is promising, it still has lower success rates than oral drugs. Importantly, this OTC option shifts some decision-making from doctors to consumers, which could delay detection of serious health issues like cardiovascular disease. The approval signifies both a leap in accessibility and the need for heightened awareness and education.

Expert Comment

Arthur L. Burnett, MD, MBA, Professor of Urology at Johns Hopkins University and an expert in erectile dysfunction, notes:

“An over-the-counter gel that works in about 10 minutes is a novel, convenient option, which marks a milestone in ED treatment. Men who are uncomfortable seeking a prescription or who can’t tolerate oral medications may find it especially appealing. But we must proceed with caution. Erectile dysfunction is often a sign of underlying cardiovascular issues, and bypassing a physician’s evaluation could delay diagnosis of serious conditions like hypertension or heart disease. Additionally, while the gel works quickly, its effectiveness appears lower than that of the well-established oral drugs. Clear communication and guidance are essential to ensure men use it safely and understand when professional medical advice is still needed.”

Who Could Benefit

Men with mild to moderate ED who prefer faster, discreet treatment or cannot tolerate oral medications.
Those hesitant to consult a doctor due to privacy concerns or healthcare access issues.
Healthcare providers, especially pharmacists and primary care physicians, who will need to advise patients on proper use and screening.
Public health systems, by increasing access to ED treatment, though requiring education on when medical evaluation is essential.

Limitations & Uncertainties

Efficacy rates (60–70%) are lower than traditional oral PDE5 inhibitors (≈80–90%).
Long-term safety of daily or frequent use has not yet been established.
Users may delay or skip medical evaluation, missing possible underlying health risks.
Some partners may experience discomfort, though rare, and partner safety needs monitoring.
OTC availability could lead to misuse or over-reliance, especially in individuals with contraindications (e.g., nitrate therapy).

What Happens Next

Manufacturers and regulatory bodies should monitor real-world use via post-marketing surveillance for side effects and misuse. Further studies are needed to compare efficacy across age groups, comorbid conditions (like diabetes), and long-term user behavior. Healthcare providers and public health organizations must also craft clear education strategies to ensure safe access while maintaining health screening standards.

Summary

A new gel for erectile dysfunction works in as little as 10 minutes and is now available without a prescription. It’s fast and easy, but it’s still important to consult a doctor, as ED can be a sign of broader health issues. This could be a helpful option for many, as long as it’s used responsibly.

Glossary

Erectile Dysfunction (ED): Inability to get or keep an erection sufficient for sexual activity.
PDE5 Inhibitors: Oral drugs (e.g., Viagra) that enhance blood flow to the penis; typically prescription-only.
Alprostadil: A vasodilator used in injectable or suppository form; not part of the new OTC gel formulation.
Over-the-Counter (OTC): Medications available without prescription.
Post-Marketing Surveillance: Tracking a drug’s safety and effectiveness after it reaches the market.

References

American Sexual Health Association. (2025, February 6). FDA approves a topical erectile dysfunction treatment, and it’s over the counter. ASHA. https://www.ashasexualhealth.org/fda-approves-a-topical-erectile-dysfunction-treatment-and-its-over-the-counter/
FDA Roundup. (2023, June 13). FDA greenlights first over-the-counter gel for erectile dysfunction (Eroxon/MED3000). U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-roundup-june-13-2023
Solan, M. (2023, September 1). FDA approves new over-the-counter gel for erectile dysfunction. Harvard Men’s Health Watch. https://www.health.harvard.edu/mens-health/fda-approves-new-over-the-counter-gel-for-erectile-dysfunction
Allo Health. (2025, February). Erection gels for erectile dysfunction: Top picks & benefits. Allo Health. https://www.allohealth.com/blog/sexual-dysfunction/erectile-dysfunction/erection-gel