MucoPEG™

Primary DI
08809334440016
Brand
MucoPEG™
Company
SunBio, Inc.
Model
SBMD-MU-001
Device description
MucoPEG™ is an artificial saliva intended to relieve the symptoms and discomfort of xerostomia (dry mouth) and was developed by SunBio, Inc. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The full chemical name of this ingredient is PEG tetra succinimidyl glutarate (PEG-SG). The additives in MucoPEG™ include mint for flavor and sodium bicarbonate for pH maintenance when dissolved in water. MucoPEG™ is formulated as a powder and packaged in a single-use packet. In general, PEG is well known for its excellent moisturizing effect in aqueous solutions due to its superior water-retaining capability. Therefore, the PEG derivative in MucoPEG™ also naturally exhibits the hydrophilic characteristics of PEG. Once in contact with the mucosa, the hydrophilic water-retaining property of PEG helps moisturize and lubricate the oral mucosa, thereby helping to relieve oral dryness. The oral mucosa of xerostomia patients consists of damaged epithelial cell layers caused by dryness. When MucoPEG™ is applied to the mucosa of xerostomia patients, it effectively fills and coats the damaged epithelial areas to relieve dry mouth symptoms and discomfort.
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LFDSaliva, Artificial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFDSaliva, ArtificialUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190144000MucoPEGSunbio, Inc.2019-11-05LFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809334440016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809334440016088093344400168809334440016

GMDN Terms#

Term, Definition table
TermDefinition
Artificial salivaAn electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
689393098
Device count
1
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
true
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 Sharing Product Codes#

Primary DI, Brand, Company table
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00350930098081Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
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00899655002220SaliveaLACLEDE, INC.LFD2025-06-16
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00850058655086Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
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05060146293129Caphosol® Artifical SalivaEUSA PHARMA (UK) LIMITEDLFD2024-06-26
08426181972769Xerostom® Saliva Substitute GelBIO COSMETICS SLLFD2024-04-01
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00858290006895Povi-OneELEVATE ORAL CARE, LLCLFD2023-09-27
00899655002213SaliveaLACLEDE, INC.LFD2023-09-22
00899655002251Salivea LACLEDE, INC.LFD2023-09-12
00899655002275SaliveaLACLEDE, INC.LFD2023-09-12
D132DMS0010CVS Dry Mouth SprayOralabs, LLCLFD2023-08-14
00858290006871Allday Spray/Gel Sample BagELEVATE ORAL CARE, LLCLFD2023-05-18
00048582001558BioteneHaleon US Holdings LLCLFD2023-04-14
00048582003309BioteneHaleon US Holdings LLCLFD2023-04-14
00048582004566BioteneHaleon US Holdings LLCLFD2023-04-14