Just Right 5000 — v3

Just Right 5000

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Version

v3

Effective date

September 19, 2025

Original packager

Yes

Sections captured

4

Identifiers

Document ID
3f2d809f-b20f-7a7d-e063-6294a90a85f4
Set ID
adf22ce4-b567-5274-e053-2a95a90a8536
Application numbers
—
Product NDCs
57511-0003
Package NDCs
57511-0003-1
Original packager NDCs
—

Names & Manufacturers

Brand names
Just Right 5000
Generic names
1.1% SODIUM FLUORIDE TOOTHPASTE
Manufacturer names
Elevate Oral Care
Product types
HUMAN PRESCRIPTION DRUG

Substances & Pharmacology

Substance names
SODIUM FLUORIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
392038
UNII
8ZYQ1474W7
UPC
—

Structured Label Sections

Instructions For Use (1)

Sequence 1

Directions Instructions for Use Directions
Package Label Principal Display Panel (1)

Sequence 1

Package label and instruction for use Primary Package Label
Spl Product Data Elements (1)

Sequence 1

Just Right 5000 1.1% Sodium Fluoride Toothpaste SODIUM FLUORIDE FLUORIDE ION WATER
Warnings (1)

Sequence 1

Warnings Warnings

OpenFDA raw payload

{'brand_name': ['Just Right 5000'],
 'generic_name': ['1.1% SODIUM FLUORIDE TOOTHPASTE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Elevate Oral Care'],
 'package_ndc': ['57511-0003-1'],
 'product_ndc': ['57511-0003'],
 'product_type': ['HUMAN PRESCRIPTION DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['392038'],
 'spl_id': ['3f2d809f-b20f-7a7d-e063-6294a90a85f4'],
 'spl_set_id': ['adf22ce4-b567-5274-e053-2a95a90a8536'],
 'substance_name': ['SODIUM FLUORIDE'],
 'unii': ['8ZYQ1474W7']}