FDA.reportPublic FDA data

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
SODIUM FLUORIDE5.4 g/108g
POTASSIUM NITRATE.26244 g/108g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038800Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
689349e4-3980-a0e4-e053-2991aa0a9ef5Available on FDA.report

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

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
Sensitive Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inc.689349e4-3980-a0e4-e053-2991aa0a9ef52018-03-29WarningsExact identifier
ndc (product): 54473-302

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