FDA.reportPublic FDA data

HyVee Inc

Product NDC
42507-188
11-digit product format
425070188
Labeler code
42507
Product ID
42507-188_80e3af92-0827-46ed-846c-80b1949ee4ce
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
HyVee Inc
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-01-20
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
0 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42507-188-892020-01-31C16284748780-19d75b9d0-0658-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-188-82HyVee IncMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1131
42507-188-89HyVee IncMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7HYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
NITRATE IONACTIVE MOIETYT93E9Y2844HYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9HYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42507-188HYVEE INC MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [HYVEE INC]1Legacy NDC, 2 package rows20121120_759481a1-0be9-4559-b2bd-5a19251ec86b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN759481a1-0be9-4559-b2bd-5a19251ec86b1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD759481a1-0be9-4559-b2bd-5a19251ec86b1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY759481a1-0be9-4559-b2bd-5a19251ec86b1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY759481a1-0be9-4559-b2bd-5a19251ec86b1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY759481a1-0be9-4559-b2bd-5a19251ec86b1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY759481a1-0be9-4559-b2bd-5a19251ec86b1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY759481a1-0be9-4559-b2bd-5a19251ec86b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42507-188-8242507018882113 g in 1 TUBE113 gHistorical
42507-188-89425070188891 in 1 CARTONHistorical