FDA.reportPublic FDA data

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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac24342d-382e-6fc2-e053-2a95a90acd69Available on FDA.report

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careac24342d-382e-6fc2-e053-2a95a90acd692025-09-19WarningsExact identifier
ndc (product): 57511-0001

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