Whitening

Product NDC
54473-301
11-digit product format
544730301
Labeler code
54473
Product ID
54473-301_47484305-ef48-52ab-e063-6394a90abf93
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-04-01
Substance
SODIUM FLUORIDE
Active strength
.26244 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
Whitening
Brand name suffix
Tooth Polish
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-301-04WhiteningTooth Polish108 g in 1 TUBEPASTE1083

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-301WHITENING TOOTH POLISH (SODIUM FLUORIDE) PASTE [MELALEUCA, INC.]1Current NDC, Legacy NDC, 1 package rows20180330_6893405a-a2c4-068e-e053-2a91aa0ae5b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN6893405a-a2c4-068e-e053-2a91aa0ae5b13
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD6893405a-a2c4-068e-e053-2a91aa0ae5b13
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY6893405a-a2c4-068e-e053-2a91aa0ae5b13
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY6893405a-a2c4-068e-e053-2a91aa0ae5b13
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY6893405a-a2c4-068e-e053-2a91aa0ae5b13
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY6893405a-a2c4-068e-e053-2a91aa0ae5b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-301-0454473030104108 g in 1 TUBE (54473-301-04) 108 g2018-01-010000-00-00NoNoCurrent