Pro-Den Rx
Approved
Approval ID
d4235a56-a82b-48f0-b72f-5f0c58f54f26
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59883-912
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2019
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.9 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM