FDA.reportPublic FDA data

Allday 5000 Sensitive

Manufacturer
Elevate Oral Care
Effective date
2025-11-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:05:05

Label at a glance#

ProductAllday 5000 Sensitive
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure3 sections

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

WarningsWarnings

Instructions for Use

INSTRUCTIONS FOR USE SECTION

Instructions for UseInstructions for Use

Primary Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package LabelPrimary Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2682752sodium fluoride 1.1 % / potassium nitrate 4.5 % ToothpastePSN2
2682752potassium nitrate 0.045 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD2
2682752K+ nitrate 0.045 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSY2
2682752Pot nitrate 0.045 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSY2
2682752potassium nitrate 4.5 % / sodium fluoride 1.1 % ToothpasteSY2

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-000657511-0006-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
XYLITOLVCQ006KQ1EIACT
MINTFV98Z8GITPIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM HYDROXIDE55X04QC32IIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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 (package): 57511-0006-1
ndc (product): 57511-0006
ndc11 (package): 57511000601
spl id: 436963b5-15ca-c8e1-e063-6294a90ae7e4
spl set id: 401f5e96-095b-c001-e063-6394a90ab55e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.