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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui392038, 2603773

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

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