FDA.reportPublic FDA data

Allday 5000

Product NDC
57511-0005
11-digit product format
575110005
Labeler code
57511
Product ID
57511-0005_3f7aeab7-532f-4ea4-e063-6294a90a6e76
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
2022-05-31
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
Allday 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
2602147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d92b84db-2202-33cc-e053-2a95a90a1753Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0005-1Allday 50001 g in 1 TUBEPASTE, DENTIFRICE13
57511-0005-1Allday 50002 in 1 BOXPASTE, DENTIFRICE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0005ALLDAY 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [ELEVATE ORAL CARE]2Current NDC, Legacy NDC, 2 package rows20240223_d92b84db-2202-33cc-e053-2a95a90a1753.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
Allday 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared92b84db-2202-33cc-e053-2a95a90a17532025-09-23WarningsExact identifier
ndc (product): 57511-0005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602147Allday 5000 1.1 % ToothpastePSNd92b84db-2202-33cc-e053-2a95a90a17533
392038sodium fluoride 1.1 % ToothpastePSNd92b84db-2202-33cc-e053-2a95a90a17533
2602147sodium fluoride 0.011 MG/MG Toothpaste [Allday]SBDd92b84db-2202-33cc-e053-2a95a90a17533
392038sodium fluoride 0.011 MG/MG ToothpasteSCDd92b84db-2202-33cc-e053-2a95a90a17533
2602147Allday 5000 0.011 MG/MG ToothpasteSYd92b84db-2202-33cc-e053-2a95a90a17533
2602147Allday 5000 1.1 % ToothpasteSYd92b84db-2202-33cc-e053-2a95a90a17533
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYd92b84db-2202-33cc-e053-2a95a90a17533
392038sodium fluoride 1.1 % Dental GelSYd92b84db-2202-33cc-e053-2a95a90a17533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57511-0005-1575110005012 TUBE in 1 BOX (57511-0005-1) / 1 g in 1 TUBE2 tube2022-05-310000-00-00NoNoCurrent