In this article
Eroxon is a non-medicated topical gel for erectile dysfunction. FDA granted its De Novo device request in 2023. The US manufacturer lists it as available without a prescription.[1][3][6]
Sources checked October 18, 2026. FDA decision record archived August 25, 2026; decision summary archived October 12, 2026. This is a product and research explainer, not a treatment recommendation.
Is Eroxon FDA approved or cleared?
The FDA database records a granted De Novo request dated June 9, 2023, under DEN220078. It names Eroxon, product code QWW, and regulation 876.5021.[1]
This is a medical-device classification, not an approval record for an oral drug. The decision summary identifies a Class II, non-medicated topical formulation.[3]
The FDA pages could not be retrieved live for this review. The dated archives above document the decision; they are not presented as a fresh FDA status search. The manufacturer's live US FAQ separately describes over-the-counter availability.[1][6]
What are Eroxon's ingredients?
The US ingredient page lists alcohol, aqua, glycerin, propylene glycol, carbomer and potassium hydroxide. It describes these as ingredients rather than active pharmaceutical ingredients.[2]
That page does not publish a percentage for each ingredient. Its ingredient list is not a home-mixing formula and does not establish equivalence to another gel.[2]
The manufacturer's application instructions describe external use on the head of the penis. This distinguishes the product format from a tablet or injection; it is not an instruction to start using it.[6]
What did Eroxon studies measure?
The records below concern different populations and study designs. They are selected primary reports, not a pooled estimate or a complete systematic review. Their numerical findings are reported without a verdict about whether Eroxon works for an individual.
| Study record | Population and follow-up | Reported measurement |
|---|---|---|
| FDA pivotal-study summary | 96 randomized men with ED; 48 assigned to Eroxon; 24 weeks.[3] | FM71 registry: mean IIEF-EF change 5.73 points, standard error 1.00, analysis n=48.[4] |
| Post-prostatectomy registry | 20 enrolled; 17 completed; 12 weeks; no comparison arm.[5] | Mean reported IIEF-EF difference 0.8 points, standard deviation 3.9, analysis n=17.[5] |
What was the FM71 comparison?
FDA describes an open-label trial with Eroxon and tadalafil arms. Its disposition table shows 47 treated and 41 completers in the Eroxon arm. FDA explicitly says the tadalafil data were not used for a comparative effectiveness assessment.[3]
The sponsor's FM71 registry result is change from baseline on the erectile-function domain of the International Index of Erectile Function, not a placebo-adjusted difference. The analysis includes imputed missing values, so its denominator is not the number completing the final visit.[4]
The registry's enrollment header and participant-flow counts differ from FDA's patient table. We retain the FDA patient denominator and the registry's endpoint-specific denominator rather than merging the two records into a larger sample.[3][4]
What was reported after prostate surgery?
Brigham and Women's Hospital registered a single-group, unblinded study in men with persistent ED after radical prostatectomy. Its results record, updated March 11, 2026, reports the small mean change shown above.[5]
The registry labels the primary outcome IIEF-EF but also supplies inconsistent scale-range and limit fields. Those fields are not used here to assign a severity category or to calculate a treatment effect. This uncontrolled postoperative sample is not interchangeable with the pivotal trial population.[5]
What does the 10-minute claim actually measure?
FM71's registry separates noticing an erection starting from being able to have penetrative sex. At 10 minutes it reports mean percentages of uses per patient of 47.81% and 31.91%, respectively, over 24 weeks. These are not percentages of all men who will respond.[4]
The archived FDA summary uses a different time label and denominator in its onset prose. That discrepancy is unresolved here; a single combined success-rate claim would conceal it.[3][4]
Do I need a prescription, and where are the instructions?
The US manufacturer says no prescription is required and describes sales through major retailers. That is an availability statement, not a determination of personal suitability.[6]
Use the leaflet supplied with the exact US package when checking instructions, ingredients and product restrictions. If a website and package differ, ask a pharmacist or clinician to identify the applicable instructions. This page does not supply a dose, schedule, combination protocol or safety conclusion.
Where can I compare clinic listings?
Regenerated.com's September 2026 export of 9,042 US clinic records includes 1,808 listings tagged Erectile Dysfunction (ED) Treatment across 49 states plus DC. Source: Regenerated.com published-clinic export, collected September 2026; independently counted from its recorded treatment tags.
This is our directory's category coverage, not a count of clinics offering Eroxon, a market-size estimate or an endorsement. The export does not establish product stock or whether a clinician recommends this gel.
Browse Erectile Dysfunction (ED) Treatment clinics, or compare listings in Texas Erectile Dysfunction (ED) Treatment clinics and Florida Erectile Dysfunction (ED) Treatment clinics. For the broader topic, see the erectile dysfunction guide.
Before arranging a visit, ask which clinician conducts the assessment, what services that location actually offers, whether product questions can be discussed, and what the consultation includes. A directory tag is not confirmation of those details.
Frequently asked questions
Is Eroxon a pill or an injection?
Neither. The manufacturer's instructions describe a topical gel applied externally, not a swallowed or injected product.[6]
Does Eroxon contain sildenafil?
Sildenafil is not on the manufacturer's published ingredient list. The listed ingredients are alcohol, aqua, glycerin, propylene glycol, carbomer and potassium hydroxide.[2]
What is Eroxon's FDA reference number?
The FDA De Novo reference is DEN220078. The archived database record gives a granted decision on June 9, 2023.[1]
Do these studies establish a result after prostate surgery?
The postoperative registry reports a small, uncontrolled study with 17 completers. That design does not provide a randomized comparison for this population or a prediction for a particular patient.[5]
Sources
- FDA: Eroxon De Novo decision; archived August 25, 2026. Checked October 18, 2026.
- Eroxon US: ingredient list; observed October 18, 2026. Checked October 18, 2026.
- FDA: Eroxon decision summary; archived October 12, 2026. Checked October 18, 2026.
- Futura Medical: FM71 results, NCT04984993; updated September 21, 2023. Checked October 18, 2026.
- Brigham and Women's Hospital: postoperative MED3000 results, NCT05673005; updated March 11, 2026. Checked October 18, 2026.
- Eroxon US: manufacturer FAQ; observed October 18, 2026. Checked October 18, 2026.