FDA.reportPublic FDA data

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

Product NDC
85162-003
Requested package NDC
85162-003-07
11-digit product format
851620003
Labeler code
85162
Product ID
85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Yangzhou ONE & ONLY Personal Care Products Co., LTD
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-16
Substance
SODIUM FLUORIDE
Active strength
.1 g/100g
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 Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb93fb1a-885a-4d2a-a1c2-3b37bc305d57Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85162-003-01Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441
85162-003-01Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth24 g in 1 TUBEPASTE, DENTIFRICE241
85162-003-02Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth24 in 1 BOXPASTE, DENTIFRICE241
85162-003-02Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth5 in 1 CARTONPASTE, DENTIFRICE51
85162-003-03Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth50 g in 1 TUBEPASTE, DENTIFRICE501
85162-003-03Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441
85162-003-04Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
85162-003-04Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 BOXPASTE, DENTIFRICE721
85162-003-05Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
85162-003-05Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441
85162-003-06Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth28 g in 1 TUBEPASTE, DENTIFRICE281
85162-003-06Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth480 in 1 BOXPASTE, DENTIFRICE4801
85162-003-07Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 BOXPASTE, DENTIFRICE721
85162-003-07Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
85162-003-08Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
85162-003-08Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85162-003PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]1Current NDC, 16 package rows20250117_bb93fb1a-885a-4d2a-a1c2-3b37bc305d57.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 37 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYbb93fb1a-885a-4d2a-a1c2-3b37bc305d571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85162-003-078516200030772 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE72 tube2025-01-16NoNoCurrent