Pro-Den Rx
Approved
Approval ID
7ac93812-7813-40a2-9f8f-9926a6e92cf9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2019
Manufacturers
FDA
Den-mat Holdings, Llc
DUNS: 809857704
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
NDC Product Code59883-824
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 28, 2019
Generic NameSodium Fluoride
INGREDIENTS (6)
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 4.3 g in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT