ProSys 5000
ProSys 5000
Approved
Approval ID
63e92d01-0982-4a04-b2ef-8b1243f3d353
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Benco Dental
DUNS: 015108087
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66975-501
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (13)
SODIUM FLUORIDEActive
Quantity: 1.1 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIB
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
MINTInactive
Code: FV98Z8GITP
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT