FDA Registration
Active
🇺🇸 United States
Haleon US HOLDINGS LLC
Reg #: 3012293198
·
FEI: 3012293198
·
Expires 2026
Products
4
Proprietary Names
23
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- Haleon US HOLDINGS LLC
- Registration Number
- 3012293198
- FEI Number
- 3012293198
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 184 LIBERTY CORNER RD
- City
- Warren
- State
- NJ
- ZIP
- 07059
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061331
Owner / Operator
- Firm Name
- Haleon
- Operator Number
- 2510369
- Address
- 184 Liberty Corner Road, --
- City
- Warren
- State
- NJ
- Postal Code
- 07059
- Country
- US
- Correspondent
- Holly Schlaudecker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Saliva, Artificial | LFD | Class U | Unknown | No | 2011-11-03 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2002-04-30 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2010-10-21 |
| Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. | QWW | Class 2 | Gastroenterology, Urology | No | 2024-09-24 |
Proprietary Names
Biotene Oral Balance Gel
DENTURE CLEANSERS (VARIOUS)
Polident Cleaner
Polident
POLIGRIP DENTURE CLEANSER TABLETS
Polident Rapid Clean: Antibacterial Dental Appliance Cleanser
Polident 3 Minute: Antibacterial Dental Appliance Cleanser
Polident Overnight Whitening: Antibacterial Dental Appliance Cleanser
Polident Smokers: Antibacterial Dental Appliance Cleanser
Biotene Mouth Spray
Sensodyne Sensitive Care Toothbrush
Parodontax Toothbrush
Sensodyne Pronamel Enamel Protection Medium Toothbrush
Polident Denture Cleaner Brush
parodontax COMPLETE PROTECTION TOOTHBRUSH
Sensodyne Pronamel Intensive Enamel Repair Soft Toothbrush
Sensodyne Sensitivity & Gum Soft Toothbrush
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
Eroxon
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility