Just Right 5000

Product NDC
57511-0001
11-digit product format
575110001
Labeler code
57511
Product ID
57511-0001_3f2cd573-ebed-738b-e063-6294a90a1f87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
1.1% Sodium Fluoride Toothpaste
Dosage form
GEL, DENTIFRICE
Route
TOPICAL
Labeler
Elevate Oral Care
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-08-05
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
Just Right 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0001-1Just Right 500097 g in 1 TUBEGEL, DENTIFRICE974

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57511-0001-1GM - Gram57511-0001d696f39b-e7df-4e46-831f-617bd411a11012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0001JUST RIGHT 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [ELEVATE ORAL CARE]3Current NDC, Legacy NDC, 1 package rows20221101_ac24342d-382e-6fc2-e053-2a95a90acd69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
392038sodium fluoride 1.1 % ToothpastePSNac24342d-382e-6fc2-e053-2a95a90acd694
392038sodium fluoride 0.011 MG/MG ToothpasteSCDac24342d-382e-6fc2-e053-2a95a90acd694
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYac24342d-382e-6fc2-e053-2a95a90acd694
392038sodium fluoride 1.1 % Dental GelSYac24342d-382e-6fc2-e053-2a95a90acd694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57511-0001-15751100010197 g in 1 TUBE (57511-0001-1) 97 g2020-08-050000-00-00NoNoCurrent