Flotrex
Flotrex (0.25 mg Fluoride) Prescribing Information
Approved
Approval ID
30186998-2121-3ef2-e063-6394a90a513e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Multivitamins, Sodium Fluoride 0.25 mg
PRODUCT DETAILS
NDC Product Code59088-017
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 2, 2025
Generic NameMultivitamins, Sodium Fluoride 0.25 mg
INGREDIENTS (20)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 1
Code: 8ZYQ1474W7
Classification: ACTIM
VITAMIN AActive
Quantity: 750 ug in 1 1
Code: 81G40H8B0T
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 24 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
SODIUM ASCORBATEActive
Quantity: 36 mg in 1 1
Code: S033EH8359
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
THIAMINE MONONITRATEActive
Quantity: 1.05 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.2 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 13.5 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1.05 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 300 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 4.5 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 6.75 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM