Eroxon

Primary DI
00307663075896
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
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079944263
Device count
8
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00307663076091EroxonEight 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
00307663076091EroxonHaleon 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