FDA.reportPublic FDA data

Plak Smacker

Product NDC
55346-0431
11-digit product format
553460431
Labeler code
55346
Product ID
55346-0431_210c6251-6601-5b6a-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL
Route
DENTAL; ORAL
Labeler
Dental Technologies, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-12-31
Marketing end
0000-00-00
Substance
STANNOUS FLUORIDE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55346-0431-22025-11-04C16284748780-19d75b9d0-5392-f424-e053-dadaa90a57ceDrug Facts
55346-0431-22020-01-31C16284748780-19d75b9d0-5392-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4
CARBOMER 934INACTIVE INGREDIENTZ135WT9208PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-0431PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]4Legacy NDC20151124_e6ffe0e7-396b-4206-861f-2f1d6de0b35d.zip