FDA.reportPublic FDA data

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

Product NDC
85162-003
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 2 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Flouride RinseSODIUM FLUORIDEYour Military Exchanges5f6f4125-6264-4724-bb7e-a6e100939b412026-08-28Warnings, Adverse reactionsExact identifier
application number: M021
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
COLGATE 2IN1 ICY BLASTSODIUM FLUORIDEColgate-Palmolive Company6aad9a91-ba1c-4a27-9269-ea8032feaad02026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact 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
85162-003-0185162000301144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-003-02851620003025 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE5 box2025-01-16NoNoCurrent
85162-003-0385162000303144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-003-048516200030472 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE72 tube2025-01-16NoNoCurrent
85162-003-0585162000305144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-003-0685162000306480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE480 tube2025-01-16NoNoCurrent
85162-003-078516200030772 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE72 tube2025-01-16NoNoCurrent
85162-003-0885162000308144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE144 tube2025-01-16NoNoCurrent