FDA.reportPublic FDA data

FluoriMax 5000 Sensitive

Manufacturer
Elevate Oral Care
Effective date
2020-08-31
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 Sensitive
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Warnings Section

Do not swallow. Keep out of reach of children under 12 years of age. Read all the instructions and prescribing information before using this product. Do not freeze or expose to extreme heat

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
2603764FluoriMax 5000 Sensitive 5 % / 1.1 % ToothpastePSN1
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN1
2603764potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SBD1
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD1
2603764Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSY1
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY1
2603764K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SY1
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY1
2603764Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SY1
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0503-1FluoriMax 5000 Sensitive96 g in 1 TUBEPASTE, DENTIFRICE961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0503FLUORIMAX 5000 SENSITIVE (1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE]1Current NDC, Legacy NDC, 1 package rows20200902_ae32b0a2-e42f-6a56-e053-2a95a90a0b00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57511-0503-1GM - Gram57511-0503f5abf26f-45fb-4a20-8633-bc3a44d3462812023-08-08

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-050357511-0503-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
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 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Cared9f232c0-d154-536b-e053-2995a90af37d2025-09-19WarningsExact identifier
ndc (package): 57511-0503-1
ndc (product): 57511-0503
ndc11 (package): 57511050301
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Careae32b0a2-e42f-6a56-e053-2a95a90a0b002020-08-31WarningsExact identifier
ndc (package): 57511-0503-1
ndc (product): 57511-0503
ndc11 (package): 57511050301
spl id: ae32b0a2-e430-6a56-e053-2a95a90a0b00
spl set id: ae32b0a2-e42f-6a56-e053-2a95a90a0b00

Reported adverse events (FAERS/openFDA)#

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