MedPath

TruGuard 5000

Professional Cleaning System

Approved
Approval ID

3b8efdcf-5beb-46c2-b118-64940a7fc74b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 25, 2023

Manufacturers
FDA

The Atlanta Dental Supply Company DBA Advanced Dental Products

DUNS: 033505389

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride Toothpaste

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71347-500
Product Classification
G
Generic Name
Sodium Fluoride Toothpaste
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (13)

SODIUM FLUORIDEActive
Quantity: 1.1 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIB
POTASSIUM NITRATEActive
Quantity: 5.0 g in 100 g
Code: RU45X2JN0Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOXYMETHYLCELLULOSEInactive
Code: 05JZI7B19X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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TruGuard 5000 - FDA Drug Approval Details