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FDA Approval

SoluVita Multivitamin Drops with Fluoride

CompanyPatrin Pharma (DUNS: 806841677)

Effective Date

April 17, 2025

Labeling Type

DIETARY SUPPLEMENT

Active Ingredients

Thiamine(0.5 mg in 1 mL)

Nicotinamide(8 mg in 1 mL)

Palmitic Acid(450 ug in 1 mL)

Vitamin C(35 mg in 1 mL)

Vitamin D3(10 ug in 1 mL)

Pyridoxine(0.4 mg in 1 mL)

Vitamin B12(2 ug in 1 mL)

Sodium fluoride(0.25 mg in 1 mL)

DL-alpha tocopheryl acetate(3.35 mg in 1 mL)

Riboflavin 5'-Phosphate Sodium(0.6 mg in 1 mL)

Products (1)

SoluVita Multivitamin Drops with Fluoride

NDC Product Code

39328-003

Route of Administration

ORAL

Effective Date

April 17, 2025

Ingredients

ThiamineActive

Code: M572600E5PClass: ACTIBQuantity: 0.5 mg in 1 mL

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 8 mg in 1 mL

Sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

SucraloseInactive

Code: 96K6UQ3ZD4Class: IACT

Sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

STRAWBERRYInactive

Code: 4J2TY8Y81VClass: IACT

CARAMELInactive

Code: T9D99G2B1RClass: IACT

Potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

Palmitic AcidActive

Code: 1D1K0N0VVCClass: ACTIMQuantity: 450 ug in 1 mL

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 35 mg in 1 mL

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 10 ug in 1 mL

PyridoxineActive

Code: 68Y4CF58BVClass: ACTIMQuantity: 0.4 mg in 1 mL

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 2 ug in 1 mL

Sodium fluorideActive

Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.25 mg in 1 mL

WaterInactive

Code: 059QF0KO0RClass: IACT

Polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

Propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

DL-alpha tocopheryl acetateActive

Code: WR1WPI7EW8Class: ACTIMQuantity: 3.35 mg in 1 mL

Riboflavin 5'-Phosphate SodiumActive

Code: 20RD1DZH99Class: ACTIMQuantity: 0.6 mg in 1 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STATEMENT OF IDENTITY SECTION

DOSAGE & ADMINISTRATION SECTION

WARNINGS SECTION

HEALTH CLAIM SECTION

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