FDA.reportPublic FDA data

CloSYS Dry Mouth Sensitive Mouth Rinse

Primary DI
00647692000132
Brand
CloSYS Dry Mouth Sensitive Mouth Rinse
Company
Rowpar Pharmaceuticals, Inc.
Model
N/A
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFDSaliva, Artificial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFDSaliva, ArtificialUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250390000CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.2025-05-19LFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647692000132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647692000132006476920001326476920001320647692000132

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-643-3337support@closys.com

Regulatory Flags#

DUNS number
783704661
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809334440016MucoPEG™SunBio, Inc.LFD2026-06-01
00350930098029Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00350930098081Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00858290006987Allday Oral Moisturizing Rinse, 10oz BottleELEVATE ORAL CARE, LLCLFD2026-05-01
00810051089004GuruNandaGurunanda, LLCLFD2026-01-28
00810051089479GuruNandaGurunanda, LLCLFD2026-01-28
00899655002220SaliveaLACLEDE, INC.LFD2025-06-16
00697366003556SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00697366003570SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00850058655086Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655055Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655109Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
05060146293129Caphosol® Artifical SalivaEUSA PHARMA (UK) LIMITEDLFD2024-06-26
08426181972769Xerostom® Saliva Substitute GelBIO COSMETICS SLLFD2024-04-01
05060146291576CaphosolEUSA PHARMA (UK) LIMITEDLFD2024-03-27
00304369600421Moi-stir 4 oz w/ sprayerCentury Pharmaceuticals IncLFD2024-02-14
00370275629047SalivaMAXForward Science Technologies LLCLFD2024-02-14
D132DMS0020CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
D132DMS0030MeijerOralabs, LLCLFD2024-01-29
00050428446102CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
00708820384446MeijerOralabs, LLCLFD2024-01-29
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