FDA.reportPublic FDA data

FluoriMax 5000

Manufacturer
Elevate Oral Care
Effective date
2025-09-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:43:40

Label at a glance#

ProductFluoriMax 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

Package Label and Instructions for use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package LabelPrimary Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2603773Fluorimax 5000 1.1 % ToothpastePSN2
392038sodium fluoride 1.1 % ToothpastePSN2
2603773sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax]SBD2
392038sodium fluoride 0.011 MG/MG ToothpasteSCD2
2603773Fluorimax 0.011 MG/MG ToothpasteSY2
2603773Fluorimax 5000 1.1 % ToothpasteSY2
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY2
392038sodium fluoride 1.1 % Dental GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0504-1FluoriMax 500096 g in 1 TUBEPASTE, DENTIFRICE962
57511-0504-2FluoriMax 50002 in 1 BOXPASTE, DENTIFRICE22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57511-0504-1GM - Gram57511-050436551a61-0e2f-4ef3-9b28-c46ce348f51012023-08-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-050457511-0504-1, 57511-0504-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
SACCHARINFST467XS7DIACT
SORBITOL506T60A25RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared9e462d9-f0fd-4168-e053-2995a90a95b22025-09-19WarningsExact identifier
ndc (package): 57511-0504-2
ndc (package): 57511-0504-1
ndc (product): 57511-0504
ndc11 (package): 57511050401
ndc11 (package): 57511050402
spl id: 3f2c7ba3-31fd-ad52-e063-6394a90a2133
spl set id: d9e462d9-f0fd-4168-e053-2995a90a95b2
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careae45ae2d-a21f-0a05-e053-2995a90a4d5e2020-09-01WarningsExact identifier
ndc (package): 57511-0504-1
ndc (product): 57511-0504
ndc11 (package): 57511050401

Reported adverse events (FAERS/openFDA)#

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