# ED creams and gels: what is approved, and what is not > No ED cream or gel is an FDA-approved drug in the US. The one topical product FDA has authorized for ED is Eroxon, a drug-free gel classified as a nonprescription device. Alprostadil cream (Vitaros) is a prescription medicine in the UK and parts of Europe. Sildenafil and tadalafil creams are not FDA-approved. _Last updated: 2026-10-18_ --- Status: Not FDA-approved for ED in the US (applies to alprostadil cream and to any sildenafil or tadalafil cream or gel); Eroxon gel is a device whose De Novo request FDA granted, classified Class II. Source: FDA Drugs@FDA and FDA De Novo database, checked 2026-10-17. **In short:** people searching for the best cream for erectile dysfunction usually find three very different things under one label. One is a drug-free gel that FDA authorized as a device. One is a prescription alprostadil cream approved in the UK and parts of Europe but not in the US. The rest are compounded creams or products sold as supplements, none of which FDA has approved. There is no single "best" cream: which treatment fits a man depends on his health and other medicines, and that choice belongs with a clinician. This page sorts out what each product is and what regulators have actually decided. | Product | What it is | US status | Elsewhere | | --------------------------------------------- | -------------------------------------------- | ---------------------------------------------------------------------------- | ------------------------------------------------------------------------------ | | Eroxon gel | Drug-free gel, regulated as a medical device | De Novo request granted June 2023; Class II; labeled for nonprescription use | Not covered here | | Alprostadil cream (Vitaros) | Prescription drug cream | Not FDA-approved; no alprostadil cream in Drugs@FDA | Prescription-only medicine in the UK; authorized in several European countries | | Sildenafil or tadalafil cream or gel | Usually compounded | Not FDA-approved; no topical form in Drugs@FDA | Not covered here | | "Male enhancement" creams sold as supplements | Non-drug products | FDA does not approve these before sale | Not covered here | | Nitroglycerin ointment | A nitrate medicine, not an ED product | FDA-approved for other conditions | Must not be combined with ED pills | Sources: [FDA De Novo database, DEN220078](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220078); [Vitaros SmPC, emc](https://www.medicines.org.uk/emc/product/13937/smpc); [Drugs@FDA](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm), searched 2026-10-17; [FDA, Compounding Q&A](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers); [FDA, avoiding contaminated products](https://www.fda.gov/drugs/medication-health-fraud/avoiding-products-contaminated-hidden-ingredients); [Rectiv label, DailyMed](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=603aa9ed-54c4-4a35-ade4-690fa44850e4). ## What is the best cream for erectile dysfunction? No cream or gel is an FDA-approved ED drug in the US, so there is no approved "best" cream to name. The only topical ED product FDA has authorized is Eroxon, a drug-free device gel, and the drug cream on this page that regulators have approved is alprostadil cream, approved in the UK and parts of Europe ([FDA De Novo database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220078); [Vitaros SmPC](https://www.medicines.org.uk/emc/product/13937/smpc)). The American Urological Association says "all men should be informed of all treatment options that are not medically contraindicated" ([AUA guideline]()), and those options are wider than creams. The AUA guideline names the options men should be told about: PDE5 inhibitor pills, vacuum erection devices, urethral alprostadil, injections and penile implants ([AUA guideline]()). Our overview of [ED treatment options](/ed-treatment-options/) walks through each one and where it fits. ## Is there an FDA-authorized topical ED gel? Yes, one: Eroxon, made by Futura Medical. FDA granted its De Novo request on June 9, 2023, creating a new device type called a "non-medicated topical formulation for treatment of erectile dysfunction," classified as Class II ([FDA De Novo database, DEN220078](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220078)). Because it went through FDA's device pathway, the accurate words are "authorized" or "classified," not "FDA-approved drug." FDA's decision summary describes Eroxon as a "non-medicated, hydro-alcoholic gel." As it evaporates it creates a cooling and then warming effect that FDA says stimulates nerve endings ([FDA decision summary, DEN220078](https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN220078.pdf)). It is indicated for ED in adult men aged 22 and over, and FDA found its labeling met the rules for over-the-counter devices. The label says to stop if irritation such as burning, itching or redness appears, and not to use it with any disease or deformity of the penis or on damaged skin. Our page on [whether Viagra is available over the counter](/is-viagra-over-the-counter/) covers where Eroxon sits among nonprescription products. ## How strong is the evidence for Eroxon? The evidence is real but limited. The main study was open-label, meaning participants knew what they were using, and 48 men were assigned to the gel ([FDA decision summary](https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN220078.pdf)). Their erectile function scores rose by an average of 5.73 points from where they started on a standard questionnaire, and FDA counted 62% as responders. There was no placebo group: a tadalafil group was included, but FDA states its data were "not used for comparison" with Eroxon. The study also left out many men who might consider the gel. It excluded men taking PDE5 inhibitors such as sildenafil or tadalafil, men on any form of organic nitrate, and men with a history of radical prostatectomy or severe or uncontrolled diabetes (same source). So it gives no information on how Eroxon behaves in those groups. One man in the Eroxon group reported a treatment-related side effect, a mild burning sensation where it was applied. ## What is alprostadil cream, and where is it approved? Alprostadil cream, sold as Vitaros, is a prescription medicine applied to the tip of the penis. Its UK product information lists it as a prescription-only medicine for men 18 and over with ED ([Vitaros SmPC, emc](https://www.medicines.org.uk/emc/product/13937/smpc)). Alprostadil is the same drug used in FDA-approved ED injections; it widens blood vessels in the erectile tissue, which works differently from the ED pills. The UK label says each patient should be shown how to apply it by a medical professional first, and that the starting dose should be recommended by a physician. Approval goes beyond the UK. A Dutch public assessment report records a decentralised procedure covering the Netherlands and nine other European countries, including Germany, Belgium and Sweden, that ended with a positive outcome for Vitaros cream on May 7, 2015 ([Dutch Medicines Evaluation Board public assessment report](https://www.geneesmiddeleninformatiebank.nl/pars/h115134.pdf)). Being authorized does not mean a product is stocked in every pharmacy in those countries. ## Is alprostadil cream approved in the US? No. Drugs@FDA lists FDA-approved alprostadil only as injections and as a urethral suppository, with no cream or other topical form ([Drugs@FDA](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm), searched 2026-10-17). An approval history compiled by Drugs.com shows that a 2017 resubmission of the US application for Vitaros received a complete response letter from FDA in February 2018, and lists Vitaros as not FDA-approved ([Drugs.com, Vitaros approval history](https://www.drugs.com/history/vitaros.html)). The research itself looks promising but uneven. A 2025 meta-analysis of topical and urethral alprostadil found topical cream improved erectile function scores by 4.7 points over placebo, but the authors note the "low methodological quality of the included studies" limits how strong the conclusion can be ([Papadopoulos et al., Andrology, 2025](https://pubmed.ncbi.nlm.nih.gov/40105058/)). For the alprostadil routes that are FDA-approved, see our guide to [ED injections and urethral suppositories](/ed-injections-and-suppositories/). ## What does the alprostadil cream label warn about? The UK label lists real cautions even though the cream goes on the skin. It says not to combine it with PDE5 inhibitors such as sildenafil, tadalafil or vardenafil, because "an additive increased cardiovascular risk cannot be excluded" ([Vitaros SmPC](https://www.medicines.org.uk/emc/product/13937/smpc)). Dizziness and fainting occurred in a small share of trial patients, and prolonged erections were rare but seen. The label says an erection lasting 4 hours or more needs immediate medical help; our page on [priapism](/priapism/) explains why. The label also covers partners and other groups. It says partners can have side effects, most often vaginal irritation, and recommends a condom, including with any partner who is or could become pregnant. It should not be used by men with underlying disorders such as low blood pressure on standing, heart attack or fainting, conditions that raise the risk of priapism such as sickle cell anemia, or unstable heart or blood-vessel conditions that make sexual activity inadvisable (same source). ## Is sildenafil cream approved? No. FDA has not approved any sildenafil cream or gel, and the same is true for tadalafil, vardenafil and avanafil. When we searched Drugs@FDA on 2026-10-17, sildenafil was listed only as tablets, an oral film, oral suspensions and an intravenous solution, and tadalafil only as tablets, a chewable tablet, capsules and an oral suspension ([Drugs@FDA](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm)). A sildenafil or tadalafil cream offered for sale is therefore either compounded or sold outside the approval system. Status: Compounded: not FDA-approved. Source: FDA, Compounding and the FDA: Questions and Answers, checked 2026-10-17. FDA is direct about what that means: "Compounded drugs are not FDA-approved," and FDA "does not verify the safety, effectiveness or quality of compounded drugs before they are marketed" ([FDA, Compounding Q&A](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers)). It adds that compounded drugs "should only be used in patients whose medical needs cannot be met by an FDA-approved drug," and that poor compounding can produce "a drug that contains too much or too little active ingredient." Our page on [chewable and dissolving ED medications](/chewable-and-dissolving-ed-medications/) covers the approved non-tablet forms that do exist, such as a dissolving sildenafil film. ## What about creams sold as supplements or natural products? These have no FDA approval at all. FDA says it reviews and approves prescription drugs before they are sold, but it "does not approve dietary supplements, vitamins or other non-drug products before they are sold" ([FDA, avoiding contaminated products](https://www.fda.gov/drugs/medication-health-fraud/avoiding-products-contaminated-hidden-ingredients)). The same FDA page tells consumers to be "especially wary of products sold for sexual enhancement." FDA has posted hundreds of notifications about hidden ingredients in sexual enhancement products ([FDA, sexual enhancement product notifications](https://www.fda.gov/drugs/medication-health-fraud-notifications/sexual-enhancement-and-energy-product-notifications)). In one 2026 notice, FDA's lab found tadalafil not listed on a product's label and warned that it "may interact with nitrates found in some prescription drugs such as nitroglycerin" ([FDA, Anaconda Premium 500K notice](https://www.fda.gov/drugs/medication-health-fraud-notifications/anaconda-premium-500k-may-be-harmful-due-hidden-ingredient)). Our running summary of [FDA warnings on tainted ED supplements](/fda-tainted-supplement-warnings/) collects those notices. ## Why is nitroglycerin gel a problem with ED pills? Nitroglycerin is a nitrate, and nitrates in any form must not be combined with ED pills. The Viagra label contraindicates sildenafil for anyone using "organic nitrates or organic nitrites in any form either regularly and/or intermittently," because sildenafil was shown to strengthen their blood-pressure-lowering effect ([Viagra prescribing information, DailyMed](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501)). Nitroglycerin ointments are FDA-approved for other conditions, and their labels say the same thing from the other side. Rectiv, a nitroglycerin ointment that its label calls a nitrate vasodilator, used for pain from a chronic anal fissure, lists PDE5 inhibitors such as sildenafil, vardenafil and tadalafil as a contraindication and states that using it "within a few days of PDE5 inhibitors is contraindicated" ([Rectiv label, DailyMed](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=603aa9ed-54c4-4a35-ade4-690fa44850e4)). Our page on [nitrates and ED medications](/nitrates-and-ed-medications/) explains what to do if chest pain starts after taking an ED pill. Nitroglycerin tablets, sprays, patches, ointments and gels are all nitrates. ED pill labels say these medicines must not be used together, because blood pressure can drop to a dangerous level. If you use any nitrate, including an ointment for a non-heart condition, tell every prescriber before starting an ED medicine. For chest pain after taking an ED medicine, get emergency help and tell the responders what you took and when. ## When to talk to a clinician Talk to a clinician before trying any cream or gel for ED, and bring a full list of what you take, including any ointment, patch or supplement. That matters most if you have a heart condition, use any nitrate, take blood pressure medicine, or already take an ED pill, since the alprostadil cream label rules out combining it with PDE5 inhibitors ([Vitaros SmPC](https://www.medicines.org.uk/emc/product/13937/smpc)). A clinician can also look for a treatable cause behind the ED, which the same label says should be ruled out before treatment starts. If a service offers a compounded cream, it is fair to ask why an approved treatment would not meet your needs, the standard FDA itself describes for compounded drugs ([FDA, Compounding Q&A](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers)). ## Sources - [FDA, De Novo database entry DEN220078 (Eroxon)](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220078) - [FDA, De Novo decision summary DEN220078 (Eroxon)](https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN220078.pdf) - [Vitaros 3 mg/g cream, Summary of Product Characteristics (UK), emc](https://www.medicines.org.uk/emc/product/13937/smpc) - [Medicines Evaluation Board (Netherlands), public assessment report: Vitaros cream, NL/H/3144/001-002/DC](https://www.geneesmiddeleninformatiebank.nl/pars/h115134.pdf) - [Drugs.com, Vitaros FDA approval status and history](https://www.drugs.com/history/vitaros.html) - [Papadopoulos I, et al. The effect of topical and intraurethral alprostadil on erectile function: a systematic review and meta-analysis. Andrology, 2025](https://pubmed.ncbi.nlm.nih.gov/40105058/) - [FDA, Drugs@FDA database](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) - [FDA: Compounding and the FDA: Questions and Answers](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers) - [FDA: Avoiding Products Contaminated with Hidden Ingredients](https://www.fda.gov/drugs/medication-health-fraud/avoiding-products-contaminated-hidden-ingredients) - [FDA: Sexual Enhancement and Energy Product Notifications](https://www.fda.gov/drugs/medication-health-fraud-notifications/sexual-enhancement-and-energy-product-notifications) - [FDA: Anaconda Premium 500K may be harmful due to hidden ingredient (2026)](https://www.fda.gov/drugs/medication-health-fraud-notifications/anaconda-premium-500k-may-be-harmful-due-hidden-ingredient) - [Viagra (sildenafil) prescribing information, DailyMed](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501) - [Rectiv (nitroglycerin) ointment prescribing information, DailyMed](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=603aa9ed-54c4-4a35-ade4-690fa44850e4) - [American Urological Association, Erectile Dysfunction Guideline]() --- _Affiliate disclosure: some links on the web version of this site go to Bodybuilding Peptides (trybbpeptides.com), an affiliate destination, and we may earn a commission if you buy there. Our coverage is independent of that relationship. Details: https://theedreport.com/affiliate-disclosure/_