FDA.reportPublic FDA data

FluoriMax 5000

Manufacturer
Elevate Oral Care
Effective date
2020-09-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:33:23

Label at a glance#

ProductFluoriMax 5000
Active ingredientSODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

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
2603773Fluorimax 5000 1.1 % ToothpastePSN1
392038sodium fluoride 1.1 % ToothpastePSN1
2603773sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax]SBD1
392038sodium fluoride 0.011 MG/MG ToothpasteSCD1
2603773Fluorimax 0.011 MG/MG ToothpasteSY1
2603773Fluorimax 5000 1.1 % ToothpasteSY1
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY1
392038sodium fluoride 1.1 % Dental GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0504-1FluoriMax 500096 g in 1 TUBEPASTE, DENTIFRICE961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0504FLUORIMAX 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE]1Current NDC, Legacy NDC, 1 package rows20200902_ae45ae2d-a21f-0a05-e053-2995a90a4d5e.zip

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 · 4 matching rows.

NDC Codes#

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

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 · 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): 57511-0504-1
ndc (product): 57511-0504
ndc11 (package): 57511050401
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
spl id: ae45ae2d-a220-0a05-e053-2995a90a4d5e
spl set id: ae45ae2d-a21f-0a05-e053-2995a90a4d5e

Reported adverse events (FAERS/openFDA)#

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