Florafol Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops
Florafol™ Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops
Approved
Approval ID
263e77a5-4d0e-4cec-b2d8-04fd28ce3338
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Pangea Pharmaceuticals, LLC
DUNS: 117751012
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VITAMIN A (as Retinyl Palmitate) VITAMIN C (as Ascorbic Acid) VITAMIN D3 (as Cholecalciferol) VITAMIN E (as d-Alpha-Tocopherol Acetate) VITAMIN B1 (as Thiamine HCl) VITAMIN B2 (as Riboflavin Phosphate Sodium) NIACIN (as Niacinamide) VITAMIN B6 (Pyridoxine HCl) Folate (as 69 mcg Quatrefolic ((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) VITAMIN B12 (as Cyanocobalamin) FLUORIDE (as Sodium Fluoride)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81279-100
Product Classification
G
Generic Name
VITAMIN A (as Retinyl Palmitate) VITAMIN C (as Ascorbic Acid) VITAMIN D3 (as Cholecalciferol) VITAMIN E (as d-Alpha-Tocopherol Acetate) VITAMIN B1 (as Thiamine HCl) VITAMIN B2 (as Riboflavin Phosphate Sodium) NIACIN (as Niacinamide) VITAMIN B6 (Pyridoxine HCl) Folate (as 69 mcg Quatrefolic ((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) VITAMIN B12 (as Cyanocobalamin) FLUORIDE (as Sodium Fluoride)
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (19)
VITAMIN A PALMITATEActive
Quantity: 450 ug in 1 mL
Code: 1D1K0N0VVC
Classification: ACTIM
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 mL
Code: 1C6V77QF41
Classification: ACTIB
FOLIC ACIDActive
Quantity: 117 ug in 1 mL
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 2 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
.ALPHA.-D-GLUCURONIC ACIDInactive
Code: M7Y086VB5G
Classification: IACT
ASCORBIC ACIDActive
Quantity: 36 mg in 1 mL
Code: PQ6CK8PD0R
Classification: ACTIB
NIACINAMIDEActive
Quantity: 4 mg in 1 mL
Code: 25X51I8RD4
Classification: ACTIB
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 mL
Code: 68Y4CF58BV
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
THIAMINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: M572600E5P
Classification: ACTIR
RIBOFLAVINActive
Quantity: 0.6 mg in 1 mL
Code: TLM2976OFR
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 3.35 mg in 1 mL
Code: 9E8X80D2L0
Classification: ACTIM