Eroxon

Primary DI
00792554999908
Brand
Eroxon
Company
Lil' Drug Store Products, Inc.
Model
99990
Catalog number
99990
Device description
Eroxon is a clinically proven gel treatment for adult men with erectile dysfunction, or ED, which is the inability to get or keep an erection sufficient for satisfactory sexual activity.
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220078000EroxonFutura Medical Developments Limited2023-06-09QWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792554999908PrimaryGS10
00079255499990Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792554999908007925549999087925549999080792554999908
00079255499990000792554999900792554999900079255499990

GMDN Terms#

Term, Definition table
TermDefinition
Penile cooling/warming gelA gel/jelly-like substance intended to be applied to the head of the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for sexual intercourse. The gel stimulates erection by providing a cooling effect as the volatile components (e.g., alcohol, water) evaporate, followed by a warming effect due to the body’s efferent response (thermoregulation), resulting in increased blood flow to the penis. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
093103646
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00079255499990Eroxon99990999902024-10-21
00792554902007SKYN210100902002022-09-12
00792554902014SKYN210120902012022-09-12
00792554902021SKYN210124902022022-09-12
00792554903004Lifestyles832389903002022-09-12
00792554903028Lifestyles833042903022022-09-12
00792554903035Lifestyles832436903032022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00307663076091EroxonHaleon US Holdings LLCQWW2025-04-01
00307663075896EroxonHaleon US Holdings LLCQWW2025-04-01
00079255499990EroxonLil' Drug Store Products, Inc.QWW2024-10-21
00307663074806EroxonHaleon US Holdings LLCQWW2024-09-26