Sensitive

Product NDC
54473-302
11-digit product format
544730302
Labeler code
54473
Product ID
54473-302_68933f55-0cd9-0074-e053-2991aa0adfb7
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate and Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-03
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5.4; .26244 g/108g; g/108g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sensitive
Brand name suffix
Tooth Polish
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5.4 g/108g
SODIUM FLUORIDE.26244 g/108g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038800

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-302-04SensitiveTooth Polish108 g in 1 TUBEPASTE, DENTIFRICE1081

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-302SENSITIVE TOOTH POLISH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC.]1Current NDC, Legacy NDC, 1 package rows20180330_689349e4-3980-a0e4-e053-2991aa0a9ef5.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 % ) ToothpastePSN689349e4-3980-a0e4-e053-2991aa0a9ef51
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD689349e4-3980-a0e4-e053-2991aa0a9ef51
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY689349e4-3980-a0e4-e053-2991aa0a9ef51
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY689349e4-3980-a0e4-e053-2991aa0a9ef51
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY689349e4-3980-a0e4-e053-2991aa0a9ef51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-302-0454473030204108 g in 1 TUBE (54473-302-04) 108 g2018-01-010000-00-00NoNoCurrent