Eroxon

GUDID 00307663075896

Eight single-use tubes of Eroxon gel in one carton.

Haleon US Holdings LLC

Penile cooling/warming gel

• Primary Device ID: 00307663075896
• NIH Device Record Key: a9789bcb-dcd8-4462-acee-fd2415349d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eroxon
• Version Model Number: Eight Pack
• Company DUNS: 079944263
• Company Name: Haleon US Holdings LLC
• Device Count: 8
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00307663075896 [Unit of Use]
GS1	00307663076091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220078

FDA Product Code

• QWW: Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [Eroxon]

• 00307663074806: Four single-use tubes of Eroxon gel in one carton.
• 00307663075896: Eight single-use tubes of Eroxon gel in one carton.