Clarben
Approved
Approval ID
755d80ff-33b2-4030-9a3e-7c2ec3147875
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2021
Manufacturers
FDA
Dharma Research, Inc.
DUNS: 078444642
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 Code53045-214
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateJuly 2, 2021
FDA Product Classification
INGREDIENTS (14)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 10.241 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
HYDROFLUORIC ACIDInactive
Code: RGL5YE86CZ
Classification: IACT