SmartMouth Premium Action

Product NDC
76357-175
11-digit product format
763570175
Labeler code
76357
Product ID
76357-175_7abf8d9e-22b4-4de8-b618-97f37a1fb40a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Triumph Pharmaceuticals Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-02-01
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
10 g/96.4g
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
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76357-175-00SmartMouth Premium ActionSmartMouth Advanced Clinical Formula (ACF)96.4 g in 1 TUBEPASTE, DENTIFRICE96.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76357-175SMARTMOUTH PREMIUM ACTION SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF) (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TRIUMPH PHARMACEUTICALS INC.]6Legacy NDC, 1 package rows20241225_4926e9a5-7f7a-40aa-b782-e731bfa45190.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76357-175-007635701750096.4 g in 1 TUBE (76357-175-00) 96.4 g2018-02-010000-00-00NoNoCurrent