Sorbet APF
Approved
Approval ID
e5d000b1-4210-41b8-bda9-f0bbbec37e65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2022
Manufacturers
FDA
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
DUNS: 014769301
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 Code68400-700
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateJanuary 24, 2022
FDA Product Classification
INGREDIENTS (12)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 5.6 g in 454 g
Code: 8ZYQ1474W7
Classification: ACTIM