What are the active ingredients in popular over-the-counter ED treatments?
Executive summary
The landscape of over‑the‑counter (OTC) erectile‑dysfunction (ED) products splits into a single FDA‑cleared topical gel whose listed non‑drug excipients produce a local effect, a crowded field of dietary supplements that list botanicals and amino acids (with mixed evidence), and a risky shadow market in which prescription PDE5 inhibitors sometimes appear — sometimes undeclared — in products sold as “herbal” or OTC [1] [2] [3] [4].
1. The one FDA‑cleared OTC product and its active components
The first and only OTC product cleared by the FDA for ED is a topical gel marketed as Eroxon® (also called MED3000), and its mechanism is not based on a systemic pharmaceutical but on topical excipients such as ethanol (alcohol), glycerin (glycerol) and carbomer polymers that create a rapid cooling/local sensory effect — the product labeling and press reporting emphasize those ingredients rather than sildenafil‑class drugs [1] [5] [6] [7].
2. Common herbal and supplement “actives” marketed for ED
Across supplements labeled as OTC ED aids, manufacturers commonly point to ingredients such as L‑arginine (often combined with pycnogenol), Korean red ginseng (Panax ginseng), yohimbe, carnitine (propionyl‑L‑carnitine), and dehydroepiandrosterone (DHEA); marketers present these as the active components even though clinical results are inconsistent and effect sizes vary by ingredient and population [3] [8] [2].
3. What the clinical and regulatory reporting says about evidence for supplements
Major health reporting and reviews note that some supplements — L‑arginine and ginseng among them — have some supportive studies but overall evidence is uneven and safety is not guaranteed; regulatory bodies in the U.S. do not approve these as ED drugs, so quality, dosing and purity can vary and clinical validation is weaker than for prescription therapies [8] [9] [2].
4. Prescription PDE5 inhibitors: the gold standard and the OTC gray market
Phosphodiesterase‑5 inhibitors (PDE5i) — sildenafil, tadalafil, vardenafil and avanafil — are the established oral treatments for ED approved by physicians and regulators for systemic use, but they remain prescription‑only in the U.S.; nevertheless, international OTC claims and illicitly labeled products sometimes advertise sildenafil or tadalafil analogues, and regulators have repeatedly found tadalafil or sildenafil adulteration in supplements sold as OTC “energy” or “herbal” products [10] [11] [12] [13] [4].
5. Safety, undeclared drugs, and real‑world recalls
Public health alerts and recalls underscore that some OTC or “supplement” products have been found to contain undeclared PDE5 inhibitors like tadalafil, which creates acute safety risks — especially dangerous interactions with nitrates and for people with cardiac disease — and regulators stress that products containing tadalafil cannot be lawfully marketed as dietary supplements [4] [3].
6. Who benefits from which narratives, and where caution is warranted
Supplement sellers and some review sites can emphasize convenience and “natural” marketing to capture demand driven by cost and stigma around ED, while clinical and regulatory sources warn consumers that most OTC oral products lack the FDA scrutiny and consistent dosing of prescription drugs; conversely, promoters of the topical FDA‑cleared gel highlight its regulatory clearance and rapid onset but the gel’s effect is local and mechanistic claims differ fundamentally from systemic PDE5 inhibitor action [2] [6] [1].
7. Practical takeaway from the reporting
The active ingredients that legitimately appear in OTC ED products fall into three buckets: non‑pharmaceutical topical excipients (ethanol, glycerin, carbomer) in the sole FDA‑cleared gel (Eroxon®) [1] [5], a range of botanical and amino‑acid supplements such as L‑arginine, ginseng, yohimbe, carnitine and DHEA that are marketed with uneven evidence [3] [8], and — importantly for safety — illicit or mislabeled products that may contain prescription drugs like tadalafil or sildenafil despite being sold as OTC supplements [4] [13]. The reporting makes clear that consumers and clinicians should treat OTC oral products with skepticism, check for regulatory clearance, and be alert for recalls and FDA warnings about undeclared PDE5 inhibitors [9] [4].