Eroxon

Primary DI
00307663076091
Brand
Eroxon
Company
Haleon US Holdings LLC
Model
Eight Pack
Device description
Eight single-use tubes of Eroxon gel in one carton.
Published
2025-04-01
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
00307663076091PrimaryGS10
00307663075896Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00307663076091003076630760913076630760910307663076091
00307663075896003076630758963076630758960307663075896

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
079944263
Device count
8
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00307663075896EroxonEight Pack2025-04-01
00307663074806EroxonFour Pack2024-09-26
00048582003309BioteneDry Mouth Oral Rinse2023-04-14
00048582004566BioteneDry Mouth Gentle Oral Rinse2023-04-14
00048582004580BioteneDry Mouth Gentle Oral Rinse2023-04-14
00048582100077BioteneDry Mouth Sample2023-04-14
00048582120266BioteneEcommerce Variety Pack Rinse Spray2023-04-14
00048582285422BioteneOral Rinse Twin Pack2023-04-14
00048582350410BioteneOral Rinse Twin Pack2023-04-14
00048582802209BioteneOral Rinse Dry Mouth2023-04-14
00048582001558BioteneMouth Spray2023-04-14
00048582512016BioteneOral Balance Gel2023-04-14
00048582004405Biotene Oral Rinse Dry Mouth 12023-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00307663075896EroxonHaleon US Holdings LLCQWW2025-04-01
00792554999908EroxonLil' Drug Store Products, Inc.QWW2024-10-21
00079255499990EroxonLil' Drug Store Products, Inc.QWW2024-10-21
00307663074806EroxonHaleon US Holdings LLCQWW2024-09-26