FDA.reportPublic FDA data

FluoriMax 5000 Sensitive

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 Sensitive
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
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
2603764FluoriMax 5000 Sensitive 5 % / 1.1 % ToothpastePSN2
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN2
2603764potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SBD2
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD2
2603764Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSY2
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY2
2603764K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SY2
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY2
2603764Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SY2
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY2

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
57511-0503-1FluoriMax 5000 Sensitive96 g in 1 TUBEPASTE, DENTIFRICE962
57511-0503-2FluoriMax 5000 Sensitive2 in 1 BOXPASTE, DENTIFRICE22

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 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-050357511-0503-1, 57511-0503-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARINFST467XS7DIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
POTASSIUM NITRATERU45X2JN0ZACTIB
WATER059QF0KO0RIACT
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 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Cared9f232c0-d154-536b-e053-2995a90af37d2025-09-19WarningsExact identifier
ndc (package): 57511-0503-2
ndc (package): 57511-0503-1
ndc (product): 57511-0503
ndc11 (package): 57511050302
ndc11 (package): 57511050301
spl id: 3f2bd1e3-4ba2-1bdb-e063-6294a90af9b0
spl set id: d9f232c0-d154-536b-e053-2995a90af37d
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

Reported adverse events (FAERS/openFDA)#

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