BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biotene Oral Balance Gel

    Reg #: 3012293198 · FEI: 3012293198 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Haleon US HOLDINGS LLC
    Registration Number
    3012293198
    FEI Number
    3012293198
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    184 LIBERTY CORNER RD
    City
    Warren
    State
    NJ
    ZIP
    07059
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123731

    Owner / Operator

    Firm Name
    Haleon
    Operator Number
    2510369
    Address
    184 Liberty Corner Road, --
    City
    Warren
    State
    NJ
    Postal Code
    07059
    Country
    US
    Correspondent
    Karen Soto

    Products

    Device Name Product Code
    Saliva, Artificial LFD

    Proprietary Names

    Biotene Oral Balance Gel Biotene Gentle Oral Rinse Biotene Moisturizing Spray Biotene Original Oral Rinse Biotene Dry Mouth Gentle Oral Rinse Gentle Mint Biotene Dry Mouth Oral Rinse Fresh Mint

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility