FDA.reportPublic FDA data

FluoriMax 5000

Product NDC
57511-0504
11-digit product format
575110504
Labeler code
57511
Product ID
57511-0504_3f2c7ba3-31fd-ad52-e063-6394a90a2133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
1.1% Sodium Fluoride Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Elevate Oral Care
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-15
Substance
SODIUM FLUORIDE
Active strength
1.1 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup
2603773Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9e462d9-f0fd-4168-e053-2995a90a95b2Available 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
57511-0504-1FluoriMax 500096 g in 1 TUBEPASTE, DENTIFRICE962
57511-0504-2FluoriMax 50002 in 1 BOXPASTE, DENTIFRICE22
57511-0504-1FluoriMax 500096 g in 1 TUBEPASTE, DENTIFRICE961

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

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, 2 package rows20220615_d9e462d9-f0fd-4168-e053-2995a90a95b2.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

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 (product): 57511-0504
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careae45ae2d-a21f-0a05-e053-2995a90a4d5e2020-09-01WarningsExact identifier
ndc (product): 57511-0504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2603773Fluorimax 5000 1.1 % ToothpastePSNd9e462d9-f0fd-4168-e053-2995a90a95b22
392038sodium fluoride 1.1 % ToothpastePSNd9e462d9-f0fd-4168-e053-2995a90a95b22
2603773sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax]SBDd9e462d9-f0fd-4168-e053-2995a90a95b22
392038sodium fluoride 0.011 MG/MG ToothpasteSCDd9e462d9-f0fd-4168-e053-2995a90a95b22
2603773Fluorimax 0.011 MG/MG ToothpasteSYd9e462d9-f0fd-4168-e053-2995a90a95b22
2603773Fluorimax 5000 1.1 % ToothpasteSYd9e462d9-f0fd-4168-e053-2995a90a95b22
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYd9e462d9-f0fd-4168-e053-2995a90a95b22
392038sodium fluoride 1.1 % Dental GelSYd9e462d9-f0fd-4168-e053-2995a90a95b22
2603773Fluorimax 5000 1.1 % ToothpastePSNae45ae2d-a21f-0a05-e053-2995a90a4d5e1
392038sodium fluoride 1.1 % ToothpastePSNae45ae2d-a21f-0a05-e053-2995a90a4d5e1
2603773sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax]SBDae45ae2d-a21f-0a05-e053-2995a90a4d5e1
392038sodium fluoride 0.011 MG/MG ToothpasteSCDae45ae2d-a21f-0a05-e053-2995a90a4d5e1
2603773Fluorimax 0.011 MG/MG ToothpasteSYae45ae2d-a21f-0a05-e053-2995a90a4d5e1
2603773Fluorimax 5000 1.1 % ToothpasteSYae45ae2d-a21f-0a05-e053-2995a90a4d5e1
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYae45ae2d-a21f-0a05-e053-2995a90a4d5e1
392038sodium fluoride 1.1 % Dental GelSYae45ae2d-a21f-0a05-e053-2995a90a4d5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57511-0504-15751105040196 g in 1 TUBE (57511-0504-1) 96 g2020-09-010000-00-00NoNoCurrent
57511-0504-2575110504022 TUBE in 1 BOX (57511-0504-2) / 96 g in 1 TUBE (57511-0504-1) 2 tube2022-06-150000-00-00NoNoCurrent