Toothette Oral Care Single Use System with Antiseptic Oral Rinse

Product NDC
53462-120
11-digit product format
534620120
Labeler code
53462
Product ID
53462-120_816c614e-b914-ce70-3823-e8469e45dbd7
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROGEN PEROXIDE
Dosage form
KIT
Labeler
Sage Products LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-31
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-120-602020-01-31C16284748780-19d75b9d0-234a-f424-e053-dadaa90a57ceToothette Oral Care Single Use System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-120-60Toothette Oral Care Single Use System with Antiseptic Oral Rinse1 in 1 KITKIT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-120TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]1Legacy NDC, 1 package rows20140530_816c614e-b914-ce70-3823-e8469e45dbd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN816c614e-b914-ce70-3823-e8469e45dbd71
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD816c614e-b914-ce70-3823-e8469e45dbd71
1251617cetylpyridinium chloride 0.05 % MouthwashSY816c614e-b914-ce70-3823-e8469e45dbd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53462-120-60534620120601 in 1 KITHistorical