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 32 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 8b28b857-9162-4065-b0a0-571efffe9787 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Ortho SODIUM FLUORIDE Dr Jen Natural, LLC 9dd248bf-9488-43cd-a041-e8315a05ce5d 2025-12-04 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Perio SODIUM FLUORIDE Dr Jen Natural, LLC 8c7e6d3a-49d9-4098-9d5e-e9792b373574 2025-12-04 Warnings Exact identifier application number: M021 Colgate Total Plaque Cleanse STANNOUS FLUORIDE Colgate-Palmolive Company b2980238-5bcb-467f-9e90-a307938632c2 2025-12-03 Warnings Exact identifier application number: M021 Advance White Extreme Whitening Tartar Control SODIUM FLUORIDE Church & Dwight Co., Inc. b539264f-e1ff-440b-af76-84266fe2c0a2 2025-12-02 Warnings Exact identifier application number: M021 Sensodyne Pronamel Clinical Enamel Strength Fresh Breath POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 34a1a32e-3017-f018-e063-6394a90a0230 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE AND POTASSIUM NITRATE Benco Dental 4e470ba4-60bb-1815-e063-6294a90abacc 2025-12-01 Warnings Exact identifier application number: M021 PRO-SYS SODIUM FLUORIDE Benco Dental 4e539cb2-bcbd-95fc-e063-6294a90a2121 2025-12-01 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DONG IL PHARMS CO., LTD. 44763bf6-caf3-ec69-e063-6394a90a0ee1 2025-11-25 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 44765e86-2eb2-6381-e063-6394a90a761f 2025-11-25 Warnings Exact identifier application number: M021 TheraBreath for Kids Anticavity Wacky Watermelon SODIUM FLUORIDE Church & Dwight Co., Inc. 578f8010-6b1c-4c6b-91d3-e483ace40f66 2025-11-25 Warnings Exact identifier application number: M021 Sensodyne Cavity and Sensitivity POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC d002074b-0580-4247-b3c7-121b8c098697 2025-11-24 Warnings Exact identifier application number: M021 CVS Pharmacy Enamel Guard FLUORIDE CVS Pharmacy 18295a1c-c2a6-489b-be34-9252b9e1e2b8 2025-11-21 Warnings Exact identifier application number: M021 365 Everyday Value Cavity Fighting and Whitening SODIUM MONOFLOUROPHOSPHATE Whole Foods Market, Inc. 83704717-19bc-2634-e053-2991aa0a2979 2025-11-21 Warnings Exact identifier application number: M021 Whitening MONOFLUOROPHOSPHATE Target 0074630f-9d8d-9209-e063-6294a90a4f01 2025-11-21 Warnings Exact identifier application number: M021 Rite Aid Enamel Guard FLUORIDE Rite Aid 67c1fc04-0f21-4944-8b9d-0d8ffd051874 2025-11-21 Warnings Exact identifier application number: M021 ME MOTHER EARTH ZERO WASTE TOOTHPASTE TABLETS PEPPERMINT A PLUS MERCHANDISE LLC 43d30abc-889a-5377-e063-6294a90ab804 2025-11-17 Warnings Exact identifier application number: M021 Natural White Sensitivity and Gum STANNOUS FLUORIDE Lornamead Products 2e83bda8-4d4b-640f-e063-6294a90abc60 2025-11-14 Warnings Exact identifier application number: M021 CVS Pharmacy Restore and Defend FLUORIDE CVS Pharmacy 99f86135-05b7-42b1-aef5-df4513259b8f 2025-11-14 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