FDA.reportPublic FDA data

Just Right 5000

Manufacturer
Elevate Oral Care
Effective date
2025-09-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:43:37

Label at a glance#

ProductJust Right 5000
Active ingredientSODIUM FLUORIDE
Label structure3 sections

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

WarningsWarnings

Directions Instructions for Use

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

Primary Package label and instruction for use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package LabelPrimary Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
392038sodium fluoride 1.1 % ToothpastePSN4
392038sodium fluoride 0.011 MG/MG ToothpasteSCD4
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY4
392038sodium fluoride 1.1 % Dental GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0001-1Just Right 500097 g in 1 TUBEGEL, DENTIFRICE974

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57511-0001-1GM - Gram57511-0001d696f39b-e7df-4e46-831f-617bd411a11012023-08-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-000157511-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careac24342d-382e-6fc2-e053-2a95a90acd692025-09-19WarningsExact identifier
ndc (package): 57511-0001-1
ndc (product): 57511-0001
ndc11 (package): 57511000101
spl id: 3f2cd573-ebed-738b-e063-6294a90a1f87
spl set id: ac24342d-382e-6fc2-e053-2a95a90acd69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.