MedActive Patient Friendly

Product NDC
49741-1007
11-digit product format
497411007
Labeler code
49741
Product ID
49741-1007_d4646175-37dc-12f1-e053-2a95a90aab1c
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
KIT
Route
ORAL
Labeler
Integrate Oral Care, LLC.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-31
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
49741-1007-22023-01-30C16284748780-1f386c64a-1aff-0266-e053-dadaa90a7c1a18cc93a4-0ddf-1fa9-e054-00144ff88e88
49741-1007-32023-01-30C16284748780-1f386c64a-1aff-0266-e053-dadaa90a7c1a18cc93a4-0ddf-1fa9-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49741-1007-1MedActive Patient Friendly1 in 1 CARTONKIT112
49741-1007-2MedActive Patient Friendly10 in 1 BOXKIT1012
49741-1007-3MedActive Patient Friendly1 in 1 CARTONKIT112
49741-1007-3MedActive Patient Friendly30 in 1 BOXKIT3012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [MEDACTIVE ORAL PHARMACEUTICALS, LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49741-1007MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [INTEGRATE ORAL CARE, LLC.]12Legacy NDC, 4 package rows20211231_18cc93a4-0ddf-1fa9-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654969MedActive Oral Relief Rinse 0.1 % Oral RinsePSN18cc93a4-0ddf-1fa9-e054-00144ff88e8812
1654967stannous fluoride 0.1 % Oral RinsePSN18cc93a4-0ddf-1fa9-e054-00144ff88e8812
583459stannous fluoride 0.63 % Dental SolutionPSN18cc93a4-0ddf-1fa9-e054-00144ff88e8812
1654969stannous fluoride 1 MG/ML Mouthwash [MedActive Rinse]SBD18cc93a4-0ddf-1fa9-e054-00144ff88e8812
1654967stannous fluoride 1 MG/ML MouthwashSCD18cc93a4-0ddf-1fa9-e054-00144ff88e8812
583459stannous fluoride 6.3 MG/ML MouthwashSCD18cc93a4-0ddf-1fa9-e054-00144ff88e8812
1654969MedActive Oral Relief Rinse 0.1 % MouthwashSY18cc93a4-0ddf-1fa9-e054-00144ff88e8812
1654969MedActive Rinse 1 MG/ML MouthwashSY18cc93a4-0ddf-1fa9-e054-00144ff88e8812
583459stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental SolutionSY18cc93a4-0ddf-1fa9-e054-00144ff88e8812
583459stannous fluoride 0.63 % Dental SolutionSY18cc93a4-0ddf-1fa9-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49741-1007-1497411007011 in 1 CARTONHistorical
49741-1007-24974110070210 CARTON in 1 BOX (49741-1007-2) > 1 KIT in 1 CARTON (49741-1007-1) * 3.7 mL in 1 KIT * 27 mL in 1 KIT10 carton2014-07-310000-00-00NoNoCurrent
49741-1007-34974110070330 CARTON in 1 BOX (49741-1007-3) > 1 KIT in 1 CARTON * 3.7 mL in 1 KIT * 27 mL in 1 KIT30 carton2014-07-310000-00-00NoNoCurrent