FDA.reportPublic FDA data

Plak Smacker

Product NDC
55346-0414
11-digit product format
553460414
Labeler code
55346
Product ID
55346-0414_210c8016-397a-2c75-e054-00144ff8d46c
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
55346-0414-22025-11-04C16284748780-19d75b9d0-805c-f424-e053-dadaa90a57ceDrug Facts
55346-0414-22020-01-31C16284748780-19d75b9d0-805c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3
CARBOMER 934INACTIVE INGREDIENTZ135WT9208PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55346-0414PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]3Legacy NDC20151124_f38df8ef-b2c9-431e-9062-828b8c77d466.zip