Family Wellness Sensitive Extra Whitening

Product NDC
55319-900
11-digit product format
553190900
Labeler code
55319
Product ID
55319-900_f06fee99-2d1b-4adf-a5a0-9e90db64a461
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate and Sodium Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Family Wellness
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-11
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5 mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-900-012019-11-27C16284748780-19855d018-eab3-cd31-e053-dbdaa90ab51aFamily Wellness Sensitive Extra Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-900-01Family Wellness Sensitive Extra Whitening113 g in 1 TUBEPASTE1131

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
NITRATE IONACTIVE MOIETYT93E9Y2844FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
SORBITOLINACTIVE INGREDIENT506T60A25RFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1
WATERINACTIVE INGREDIENT059QF0KO0RFAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-900FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]1Legacy NDC, 1 package rows20130423_22b5d423-b43a-4be9-be98-998640ff1c13.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 % ) ToothpastePSN22b5d423-b43a-4be9-be98-998640ff1c131
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD22b5d423-b43a-4be9-be98-998640ff1c131
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY22b5d423-b43a-4be9-be98-998640ff1c131
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY22b5d423-b43a-4be9-be98-998640ff1c131
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY22b5d423-b43a-4be9-be98-998640ff1c131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55319-900-0155319090001113 g in 1 TUBE113 gHistorical