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 3 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SprinJene White Boost SODIUM FLUORIDE Health and Natural Beauty USA Corp 8c401bea-0148-46a0-bbb3-80c17f9e8e3e 2026-08-14 Warnings Exact identifier application number: M021 ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company 2b123d70-4f7d-41b0-b48f-711999e97ee0 2026-08-13 Warnings Exact identifier application number: M021 COLGATE STRAWBERRY BURST SODIUM FLUORIDE Colgate-Palmolive Company d037f65c-3d22-4d2a-a0a9-3dcba2357ebd 2026-08-13 Warnings Exact identifier application number: M021 COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company cd954777-697a-4cc7-8f5f-b2caf357ef95 2026-08-13 Warnings Exact identifier application number: M021 TOMS OF MAINE KIDS SILLY STRAWBERRY SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. e36ceb7a-9a29-41d8-8d08-a859e515f1f5 2026-08-13 Warnings Exact identifier application number: M021 TOMS OF MAINE WHOLE CARE SPEARMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 08d7ed04-67a4-437a-82c5-496f9893c6c7 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED FRESH COOL PEPPERMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 27278b02-c4fd-4092-a632-a14e442f5a95 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED FRESH SPEARMINT ICE SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 59a6b9ac-c28b-4ec3-8231-f35054ce0eaf 2026-08-10 Warnings Exact identifier application number: M021 Toms Kids Watermelon Wiggle SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids bubblegum SODIUM FLUORIDE Lander Enterprises, LLC 64b60e74-fceb-4de9-a966-73bf8dbd666c 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids strawberry SODIUM FLUORIDE Lander Enterprises, LLC 7e880d50-8aab-4d57-abc1-e900070f9a11 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids watermelon SODIUM FLUORIDE Lander Enterprises, LLC 5cb5eb46-705c-4bb7-bef1-e93a598636fd 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush Mint SODIUM FLUORIDE Lander Enterprises, LLC 0e043431-9d87-478d-87f5-5aa8b0a932eb 2026-08-10 Warnings Exact identifier application number: M021 Willo Minty Mist Dye Free SODIUM FLUORIDE Willo 32, Inc. 3ee5b49e-ca9a-ece6-e063-6394a90a3d00 2026-08-10 Warnings Exact identifier application number: M021 Willo Bubble Twist SODIUM FLUORIDE Willo 32 Inc 36560d62-e901-1f93-e063-6394a90a2803 2026-08-10 Warnings Exact identifier application number: M021 Willo Berry Splash Dye Free SODIUM FLUORIDE Willo 32, Inc 3ea91af9-2895-e530-e063-6394a90a39e5 2026-08-10 Warnings Exact identifier application number: M021 Fluoride Mouth Rinse Anticavity SODIUM FLUORIDE Target Corporation 3daf3cc3-585a-4bb2-9b56-7117d220ed38 2026-08-10 Warnings, Adverse reactions Exact identifier application number: M021 TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 19de1e71-ab94-415f-b66d-e5748dea8317 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WHOLE CARE WINTERMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. d5e1396e-0253-4ec0-a9ff-b61bda70de35 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED COOL MILD MINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. de92408c-d401-47c3-94ee-fb6c08092651 2026-08-10 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