FDA.reportPublic FDA data

FluoriMax 5000 Sensitive

Product NDC
57511-0503
11-digit product format
575110503
Labeler code
57511
Product ID
57511-0503_3f2bd1e3-4ba2-1bdb-e063-6294a90af9b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Elevate Oral Care
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-15
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; 1.1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FluoriMax 5000 Sensitive
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 g/100g
POTASSIUM NITRATE1.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637365Internal RxNorm lookup
2603764Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9f232c0-d154-536b-e053-2995a90af37dAvailable on FDA.report

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
57511-0503-1FluoriMax 5000 Sensitive96 g in 1 TUBEPASTE, DENTIFRICE961

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

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, 2 package rows20220615_d9f232c0-d154-536b-e053-2995a90af37d.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

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 (product): 57511-0503
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Careae32b0a2-e42f-6a56-e053-2a95a90a0b002020-08-31WarningsExact identifier
ndc (product): 57511-0503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2603764FluoriMax 5000 Sensitive 5 % / 1.1 % ToothpastePSNd9f232c0-d154-536b-e053-2995a90af37d2
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSNd9f232c0-d154-536b-e053-2995a90af37d2
2603764potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SBDd9f232c0-d154-536b-e053-2995a90af37d2
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCDd9f232c0-d154-536b-e053-2995a90af37d2
2603764Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSYd9f232c0-d154-536b-e053-2995a90af37d2
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYd9f232c0-d154-536b-e053-2995a90af37d2
2603764K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SYd9f232c0-d154-536b-e053-2995a90af37d2
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYd9f232c0-d154-536b-e053-2995a90af37d2
2603764Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SYd9f232c0-d154-536b-e053-2995a90af37d2
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSYd9f232c0-d154-536b-e053-2995a90af37d2
2603764FluoriMax 5000 Sensitive 5 % / 1.1 % ToothpastePSNae32b0a2-e42f-6a56-e053-2a95a90a0b001
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSNae32b0a2-e42f-6a56-e053-2a95a90a0b001
2603764potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SBDae32b0a2-e42f-6a56-e053-2a95a90a0b001
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCDae32b0a2-e42f-6a56-e053-2a95a90a0b001
2603764Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSYae32b0a2-e42f-6a56-e053-2a95a90a0b001
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYae32b0a2-e42f-6a56-e053-2a95a90a0b001
2603764K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SYae32b0a2-e42f-6a56-e053-2a95a90a0b001
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYae32b0a2-e42f-6a56-e053-2a95a90a0b001
2603764Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]SYae32b0a2-e42f-6a56-e053-2a95a90a0b001
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSYae32b0a2-e42f-6a56-e053-2a95a90a0b001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57511-0503-15751105030196 g in 1 TUBE (57511-0503-1) 96 g2020-08-310000-00-00NoNoCurrent
57511-0503-2575110503022 TUBE in 1 BOX (57511-0503-2) / 96 g in 1 TUBE (57511-0503-1) 2 tube2022-06-150000-00-00NoNoCurrent