FDA.reportPublic FDA data

Allday 5000 Sensitive

Product NDC
57511-0006
11-digit product format
575110006
Labeler code
57511
Product ID
57511-0006_436963b5-15ca-c8e1-e063-6294a90ae7e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
1.1% Sodium Fluoride Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Elevate Oral Care
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-11-12
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
Allday 5000 Sensitive
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE1.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2682752Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
401f5e96-095b-c001-e063-6394a90ab55eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0006-1Allday 5000 Sensitive2 in 1 BOXPASTE, DENTIFRICE22
57511-0006-1Allday 5000 Sensitive1 g in 1 TUBEPASTE, DENTIFRICE12

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
Allday 5000 Sensitive1.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Care401f5e96-095b-c001-e063-6394a90ab55e2025-11-12WarningsExact identifier
ndc (product): 57511-0006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2682752sodium fluoride 1.1 % / potassium nitrate 4.5 % ToothpastePSN401f5e96-095b-c001-e063-6394a90ab55e2
2682752potassium nitrate 0.045 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD401f5e96-095b-c001-e063-6394a90ab55e2
2682752K+ nitrate 0.045 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSY401f5e96-095b-c001-e063-6394a90ab55e2
2682752Pot nitrate 0.045 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSY401f5e96-095b-c001-e063-6394a90ab55e2
2682752potassium nitrate 4.5 % / sodium fluoride 1.1 % ToothpasteSY401f5e96-095b-c001-e063-6394a90ab55e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57511-0006-1575110006012 TUBE in 1 BOX (57511-0006-1) / 1 g in 1 TUBE2 tube2025-11-14NoNoCurrent