SoluVita Multivitamin Drops with Fluoride
SoluVita Multivitamin Drops with Fluoride
Approved
Approval ID
6263bba2-0e17-4e4e-9b27-11cc28a2b6c9
Product Type
DIETARY SUPPLEMENT
Effective Date
Apr 17, 2025
Manufacturers
FDA
Patrin Pharma
DUNS: 806841677
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vitamin A palmitate, Ascorbic acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Hydrochloride, RIBOFLAVIN 5-PHOSPHATE SODIUM DIHYDRATE, Niacinamide, Pyridoxine Hydrochloride, Cyanocobalamin, and Sodium fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39328-003
Product Classification
G
Generic Name
Vitamin A palmitate, Ascorbic acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Hydrochloride, RIBOFLAVIN 5-PHOSPHATE SODIUM DIHYDRATE, Niacinamide, Pyridoxine Hydrochloride, Cyanocobalamin, and Sodium fluoride
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (19)
Thiamine HydrochlorideActive
Quantity: 0.5 mg in 1 mL
Code: M572600E5P
Classification: ACTIB
NiacinamideActive
Quantity: 8 mg in 1 mL
Code: 25X51I8RD4
Classification: ACTIB
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
Potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
Vitamin A palmitateActive
Quantity: 450 ug in 1 mL
Code: 1D1K0N0VVC
Classification: ACTIM
Ascorbic acidActive
Quantity: 35 mg in 1 mL
Code: PQ6CK8PD0R
Classification: ACTIB
CholecalciferolActive
Quantity: 10 ug in 1 mL
Code: 1C6V77QF41
Classification: ACTIB
Pyridoxine HydrochlorideActive
Quantity: 0.4 mg in 1 mL
Code: 68Y4CF58BV
Classification: ACTIM
CyanocobalaminActive
Quantity: 2 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
Sodium fluorideActive
Quantity: 0.25 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 3.35 mg in 1 mL
Code: WR1WPI7EW8
Classification: ACTIM
RIBOFLAVIN 5'-PHOSPHATE SODIUM DIHYDRATEActive
Quantity: 0.6 mg in 1 mL
Code: 20RD1DZH99
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/17/2025
STATEMENT OF IDENTITY SECTION
LOINC: 69718-5Updated: 4/17/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/17/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/17/2025
HEALTH CLAIM SECTION
LOINC: 69719-3Updated: 4/17/2025