FDA.reportPublic FDA data

Walgreens Sensitive Extra Whitening

Product NDC
0363-1588
11-digit product format
003631588
Labeler code
0363
Product ID
0363-1588_441e7794-1c6d-ea23-e063-6294a90ad145
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Walgreens
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-28
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 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
Walgreens Sensitive Extra Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-1588-092025-12-08C16284748780-11030e365-3a23-111a-e063-dadaa90a10e25820058 Walgreens Sensitive Extra Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1588-09Walgreens Sensitive Extra Whitening1 in 1 BOXPASTE, DENTIFRICE17
0363-1588-09Walgreens Sensitive Extra Whitening113 g in 1 TUBEPASTE, DENTIFRICE1137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1588WALGREENS SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [WALGREENS]2Current NDC, Legacy NDC, 2 package rows20221029_e807b8a0-6d58-a15f-e053-2995a90a2ea1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNe807b8a0-6d58-a15f-e053-2995a90a2ea17
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDe807b8a0-6d58-a15f-e053-2995a90a2ea17
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYe807b8a0-6d58-a15f-e053-2995a90a2ea17
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYe807b8a0-6d58-a15f-e053-2995a90a2ea17
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYe807b8a0-6d58-a15f-e053-2995a90a2ea17
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYe807b8a0-6d58-a15f-e053-2995a90a2ea17
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYe807b8a0-6d58-a15f-e053-2995a90a2ea17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1588-09003631588091 TUBE in 1 BOX (0363-1588-09) / 113 g in 1 TUBE1 tube2022-10-280000-00-00NoNoCurrent