FDA.reportPublic FDA data

Sensitive Whitening Tooth-paste

Product NDC
79481-0008
11-digit product format
794810008
Labeler code
79481
Product ID
79481-0008_e9579105-80a5-440e-8da2-b31b65542f32
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Meijer, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-24
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 2.43 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sensitive Whitening Tooth-paste
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE2.43 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038800

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79481-0008-12025-12-24C16284748780-12cef2736-ab49-d83d-e063-dadaa90ab31fmeijer ​® sensitive toothpaste EXTRA WHITENING
79481-0008-12025-01-30C16284748780-12cef2736-ab49-d83d-e063-dadaa90ab31fmeijer ​® sensitive toothpaste EXTRA WHITENING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0008-1Sensitive Whitening Tooth-paste113 g in 1 TUBEPASTE, DENTIFRICE1134
79481-0008-1Sensitive Whitening Tooth-paste1 in 1 BOXPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0008SENSITIVE WHITENING TOOTH-PASTE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [MEIJER, INC.]3Current NDC, Legacy NDC, 2 package rows20230112_c25b6a95-e604-48e3-bc55-595969d1ce9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSNc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCDc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSYc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSYc25b6a95-e604-48e3-bc55-595969d1ce9b4
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYc25b6a95-e604-48e3-bc55-595969d1ce9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0008-1794810008011 TUBE in 1 BOX (79481-0008-1) / 113 g in 1 TUBE1 tube2020-12-240000-00-00NoNoCurrent