FDA.reportPublic FDA data

Plak Smacker

Product NDC
72796-0412
11-digit product format
727960412
Labeler code
72796
Product ID
72796-0412_42c89f0a-b4bb-a17b-e063-6294a90a09bf
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL
Route
DENTAL; ORAL
Labeler
Young Innovations, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-31
Substance
STANNOUS FLUORIDE
Active strength
.969 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Plak Smacker
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.969 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e65c62d9-e8a6-3101-e053-2995a90a1494Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-02-06Plak Smacker Stannous Gel - Bubble Gum
2024-02-06Plak Smacker Stannous Gel - Bubble Gum
2024-01-30Plak Smacker Stannous Gel - Bubble Gum
2024-01-30Plak Smacker Stannous Gel - Bubble Gum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72796-0412-1Plak Smacker121.9 g in 1 TUBEGEL121.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72796-0412PLAK SMACKER (STANNOUS FLUORIDE) GEL [YOUNG INNOVATIONS, INC.]2Current NDC, Legacy NDC, 1 package rows20240207_e65c62d9-e8a6-3101-e053-2995a90a1494.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 30 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPaste One PerioMIPASTE ONE PERIOGC America Inc.d656b72d-48f8-4425-e053-2995a90ab1f22025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Blue RaspberryMIPASTE ONE KIDS BLUE RASPBERRYGC America Inc.c07e1058-903b-fd47-e053-2995a90afdab2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus StrawberryMIPASTE PLUS STRAWBERRYGC America Inc.d7235ad7-83d7-12e5-e053-2a95a90aaeaf2025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Cotton CandyMIPASTE ONE KIDS COTTON CANDYGC America Inc.c07d6b50-1d67-ea7f-e053-2a95a90afbe42025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Bubble GumMIPASTE ONE KIDS BUBBLE GUMGC America Inc.c07c7853-763b-4383-e053-2995a90ab7252025-12-19WarningsExact identifier
application number: M021
MIPaste OneMIPASTE ONEGC America Inc.d71f8e6e-7005-4b3e-e053-2995a90a67892025-12-19WarningsExact identifier
application number: M021
TheraBreath AM-PM Twin PackSODIUM FLUORIDEChurch & Dwight Co., Inc.4618e390-9039-a1d0-e063-6294a90ab2942025-12-16WarningsExact identifier
application number: M021
Parodontax Gum Strengthen and ProtectSTANNOUS FLUORIDEHaleon US Holdings LLC3bb40ceb-841b-4a25-e063-6294a90ab8972025-12-15WarningsExact identifier
application number: M021
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
application number: M021
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
application number: M021
Natural Adult FluorideSODIUM MONOFLUOROPHOSPHATEKrogera71c537e-39d9-1c3b-e053-2a95a90ac3ec2025-12-15WarningsExact identifier
application number: M021
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188d28f9-a814-0f98-e063-6294a90a106b2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b4cf935-38a6-f4fb-e063-6394a90a4bc02025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba491f4-2ad2-6e7b-e063-6394a90a9fb72025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188ac743-3ba8-4da4-e063-6294a90a8f872025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b682604-c563-01f1-e063-6294a90ab0bd2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b110db1-fcc0-377f-e063-6394a90a4d442025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74ecc4-a1e6-348f-e063-6294a90a58942025-12-11Exact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72796-0412-172796041201121.9 g in 1 TUBE (72796-0412-1) 121.9 g2007-12-310000-00-00NoNoCurrent