Care One

Product NDC
41520-415
11-digit product format
415200415
Labeler code
41520
Product ID
41520-415_47e54e5e-4bd7-00ce-e063-6394a90a99e8
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
American Sales
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Care One
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-415-02Care OneMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1136
41520-415-09Care OneMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
NITRATE IONACTIVE MOIETYT93E9Y2844CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SORBITOLINACTIVE INGREDIENT506T60A25RCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
WATERINACTIVE INGREDIENT059QF0KO0RCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-415CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]5Current NDC, Legacy NDC, 2 package rows20250119_1b6618ea-6533-41d7-be2c-13bb9e108dc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-415-0241520041502113 g in 1 TUBE113 gHistorical
41520-415-09415200415091 TUBE in 1 CARTON (41520-415-09) / 113 g in 1 TUBE (41520-415-02) 1 tube2012-11-150000-00-00NoNoCurrent