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SoluVita Sodium Fluoride Drops

SoluVita Sodium Fluoride Drops

Approved
Approval ID

018ce289-f134-4951-b8b9-a02f6ae6af70

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.

sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code39328-007
Product Classification
G
Generic Name
sodium fluoride
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification

INGREDIENTS (7)

STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
Sodium FluorideActive
Quantity: 0.5 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
Ascorbic acidInactive
Code: PQ6CK8PD0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/17/2025

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 4/17/2025

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 4/17/2025

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 4/17/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 4/17/2025

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 4/17/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/17/2025

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SoluVita Sodium Fluoride Drops - FDA Drug Approval Details