FDA.reportPublic FDA data

PremierPro Fluoride Tooth

Product NDC
69392-001
11-digit product format
693920001
Labeler code
69392
Product ID
69392-001_946328f8-56db-4928-b767-30f65e8114fc
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
SVS, LLC (DBA S2S Global)
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
0 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69392-001-012020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-022020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-032020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-042020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-052020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-062020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d
69392-001-072020-01-31C16284748780-19d75b9d0-01e4-f424-e053-dadaa90a57ce7faa8f2c-c583-4a3a-9fd7-c48a439bce5d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69392-001-01PremierPro Fluoride Tooth14 g in 1 TUBEPASTE, DENTIFRICE142
69392-001-02PremierPro Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE242
69392-001-03PremierPro Fluoride Tooth42 g in 1 TUBEPASTE, DENTIFRICE422
69392-001-04PremierPro Fluoride Tooth78 g in 1 TUBEPASTE, DENTIFRICE782
69392-001-05PremierPro Fluoride Tooth85 g in 1 TUBEPASTE, DENTIFRICE852
69392-001-06PremierPro Fluoride Tooth130 g in 1 TUBEPASTE, DENTIFRICE1302
69392-001-07PremierPro Fluoride Tooth198 g in 1 TUBEPASTE, DENTIFRICE1982

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)INACTIVE INGREDIENT99H65D77XYPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
SORBITOLINACTIVE INGREDIENT506T60A25RPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2
WATERINACTIVE INGREDIENT059QF0KO0RPREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69392-001PREMIERPRO FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SVS, LLC (DBA S2S GLOBAL)]2Legacy NDC, 7 package rows20150120_7faa8f2c-c583-4a3a-9fd7-c48a439bce5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN7faa8f2c-c583-4a3a-9fd7-c48a439bce5d2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7faa8f2c-c583-4a3a-9fd7-c48a439bce5d2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7faa8f2c-c583-4a3a-9fd7-c48a439bce5d2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7faa8f2c-c583-4a3a-9fd7-c48a439bce5d2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7faa8f2c-c583-4a3a-9fd7-c48a439bce5d2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7faa8f2c-c583-4a3a-9fd7-c48a439bce5d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69392-001-016939200010114 g in 1 TUBE14 gHistorical
69392-001-026939200010224 g in 1 TUBE24 gHistorical
69392-001-036939200010342 g in 1 TUBE42 gHistorical
69392-001-046939200010478 g in 1 TUBE78 gHistorical
69392-001-056939200010585 g in 1 TUBE85 gHistorical
69392-001-0669392000106130 g in 1 TUBE130 gHistorical
69392-001-0769392000107198 g in 1 TUBE198 gHistorical