Identity
- Trade Name
- Xerostom® Saliva Substitute Gel FDA UDI
- Generic Name
- Artificial saliva FDA UDI
- Device Name
- XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth FDA UDI
- Model / Reference
- Tube 25ml FDA UDI
- Description
- XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426181972769 FDA UDI
- FDA Product Code
- LFD FDA UDI
- GMDN Term
- Artificial saliva FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Artificial saliva
Xerostom® Saliva Substitute Gel by Bio Cosmetics Sl — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial saliva.
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- Biotene — Haleon US Holdings LLC · U
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- Salivea — Laclede, Inc. · U
- SalivaMAX — FORWARD SCIENCE TECHNOLOGIES LLC · U
- Biotene Oral Rinse Dry Mouth — Haleon US Holdings LLC · U
- THERABREATH LOZENGE — Church & Dwight Co., Inc. · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Bio Cosmetics Sl
Sources (1)
- FDA UDI 23e244c1-03a3-4146-98ed-4d07bf5afe9f 34 fields · synced May 31, 2026