Home NDC 85162-003 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 Ingredient Strength SODIUM FLUORIDE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85162-003-01 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-003-01 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 24 g in 1 TUBE PASTE, DENTIFRICE 24 1 85162-003-02 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 24 in 1 BOX PASTE, DENTIFRICE 24 1 85162-003-02 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 5 in 1 CARTON PASTE, DENTIFRICE 5 1 85162-003-03 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 50 g in 1 TUBE PASTE, DENTIFRICE 50 1 85162-003-03 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-003-04 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 100 g in 1 TUBE PASTE, DENTIFRICE 100 1 85162-003-04 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 72 in 1 BOX PASTE, DENTIFRICE 72 1 85162-003-05 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 100 g in 1 TUBE PASTE, DENTIFRICE 100 1 85162-003-05 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 144 in 1 BOX PASTE, DENTIFRICE 144 1 85162-003-06 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 28 g in 1 TUBE PASTE, DENTIFRICE 28 1 85162-003-06 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 480 in 1 BOX PASTE, DENTIFRICE 480 1 85162-003-07 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 72 in 1 BOX PASTE, DENTIFRICE 72 1 85162-003-07 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 120 g in 1 TUBE PASTE, DENTIFRICE 120 1 85162-003-08 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 120 g in 1 TUBE PASTE, DENTIFRICE 120 1 85162-003-08 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth 144 in 1 BOX PASTE, DENTIFRICE 144 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85162-003 PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD] 1 Current NDC, 16 package rows 20250117_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 8 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 5500f9ab-b0c4-51d6-e063-6394a90acd38 2026-06-24 Warnings Exact identifier application number: M021 Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 5504ec96-aae1-f5f9-e063-6294a90ad8bb 2026-06-24 Warnings Exact identifier application number: M021 COLGATE SPARKLING WHITE CINNAMINT SODIUM FLUORIDE Colgate-Palmolive Company f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1 2026-06-24 Warnings Exact identifier application number: M021 Crest Plus Scope plus Whitening Minty Fresh with Mouthwash SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 54ed8e02-3c2f-750c-e063-6394a90a4d33 2026-06-23 Warnings Exact identifier application number: M021 Anticavity Fluoride Rinse SODIUM FLUORIDE H E B c68b0644-685d-4c62-bf5d-3a5bbea3b052 2026-06-22 Warnings, Adverse reactions Exact identifier application number: M021 Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. fdbadaae-eab7-4d9a-acf7-815ca93f877c 2026-06-16 Warnings Exact identifier application number: M021 Natural Fluoride Fresh Mint cavity protection whitening fresh breath SODIUM FLUORIDE Tom's of Maine, Inc. fce5e8b5-34f8-4a45-a662-82c903419809 2026-06-16 Warnings Exact identifier application number: M021 Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. ebb62015-0027-459a-a9cf-56b640f9f456 2026-06-16 Warnings Exact identifier application number: M021 Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. b9962eac-186e-4da2-929d-393f18ed0234 2026-06-16 Warnings Exact identifier application number: M021 Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 1c029b10-29b0-4131-9134-cebfca4328a3 2026-06-16 Warnings Exact identifier application number: M021 Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 3e7ab39a-989c-4924-af3e-689404912bee 2026-06-16 Warnings Exact identifier application number: M021 Crest Plus Cinnamon plus Whitening SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 53fb780d-3e8b-6747-e063-6294a90a8211 2026-06-11 Warnings Exact identifier application number: M021 Colgate Total SF Whitening STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 7f6b6aa8-50da-151b-c448-9e427d37398f 2026-06-11 Warnings Exact identifier application number: M021 Colgate MaxClean with Whitening Smartfoam SODIUM FLUORIDE Colgate-Palmolive Company c712ae6b-eff3-4c54-b1fc-37304758d059 2026-06-11 Warnings Exact identifier application number: M021 Colgate Total Sensitivity Mineral Shield STANNOUS FLUORIDE Colgate-Palmolive Company f065318c-1e2a-c04d-f254-f8127b05a88f 2026-06-10 Warnings Exact identifier application number: M021 Toms Whole Care Mouthwash Fresh Mint SODIUM FLUORIDE Tom's of Maine, Inc. 6875f5c1-853c-43da-8226-c09a5518f9bb 2026-06-10 Warnings Exact identifier application number: M021 Colgate Total SF Fresh Mint Stripe STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 657020c7-e85c-4c61-9f62-b50351e4b4e5 2026-06-10 Warnings Exact identifier application number: M021 Optimax Anticavity Fluoride Bubblegum SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 1adc752b-2ba8-4d8f-b4f1-5741f864255b 2026-06-09 Warnings Exact identifier application number: M021 Kids Crest Cavity Protection Sparkle Fun SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. df182c22-bbf1-448d-81e8-35cb431d2afc 2026-06-08 Warnings Exact identifier application number: M021 PEROXICARE SODIUM FLUORIDE Church & Dwight Co., Inc. 55262538-15ce-455c-93b1-bb02b5f81d6b 2026-06-07 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85162-003-01 85162000301 144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-003-02 85162000302 5 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE 5 box 2025-01-16 No No Current 85162-003-03 85162000303 144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-003-04 85162000304 72 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE 72 tube 2025-01-16 No No Current 85162-003-05 85162000305 144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE 144 tube 2025-01-16 No No Current 85162-003-06 85162000306 480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE 480 tube 2025-01-16 No No Current 85162-003-07 85162000307 72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE 72 tube 2025-01-16 No No Current 85162-003-08 85162000308 144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE 144 tube 2025-01-16 No No Current