SmartMouth Advance Clinical DDS Formula Mint

Product NDC
76357-230
11-digit product format
763570230
Labeler code
76357
Product ID
76357-230_5008b055-cd52-4cb1-bb98-700050415f94
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
KIT
Labeler
Triumph Pharmaceuticals, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-12-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76357-230-012024-01-30C16284748780-11030e365-292b-111a-e063-dadaa90a10e2SmartMouth™ Advance Clinical DDS™ Formula Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-230-01SmartMouth Advance Clinical DDS Formula Mint1 in 1 POUCHKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-230SMARTMOUTH ADVANCE CLINICAL DDS FORMULA MINT (CETYLPYRIDINIUM CHLORIDE) KIT [TRIUMPH PHARMACEUTICALS, INC.]6Legacy NDC, 1 package rows20241215_4dad79f6-f922-4c22-8568-2d9105348a84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN4dad79f6-f922-4c22-8568-2d9105348a846
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD4dad79f6-f922-4c22-8568-2d9105348a846
1251617cetylpyridinium chloride 0.05 % MouthwashSY4dad79f6-f922-4c22-8568-2d9105348a846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76357-230-01763570230011 KIT in 1 POUCH (76357-230-01) * 10 mL in 1 POUCH * 10 mL in 1 POUCH1 kit2019-12-010000-00-00NoNoCurrent