Home NDC 85162-003-07 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 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 30 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MIPaste One Perio MIPASTE ONE PERIO GC America Inc. d656b72d-48f8-4425-e053-2995a90ab1f2 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One Kids Blue Raspberry MIPASTE ONE KIDS BLUE RASPBERRY GC America Inc. c07e1058-903b-fd47-e053-2995a90afdab 2025-12-19 Warnings Exact identifier application number: M021 MIPaste Plus Strawberry MIPASTE PLUS STRAWBERRY GC America Inc. d7235ad7-83d7-12e5-e053-2a95a90aaeaf 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One Kids Cotton Candy MIPASTE ONE KIDS COTTON CANDY GC America Inc. c07d6b50-1d67-ea7f-e053-2a95a90afbe4 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One Kids Bubble Gum MIPASTE ONE KIDS BUBBLE GUM GC America Inc. c07c7853-763b-4383-e053-2995a90ab725 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One MIPASTE ONE GC America Inc. d71f8e6e-7005-4b3e-e053-2995a90a6789 2025-12-19 Warnings Exact identifier application number: M021 TheraBreath AM-PM Twin Pack SODIUM FLUORIDE Church & Dwight Co., Inc. 4618e390-9039-a1d0-e063-6294a90ab294 2025-12-16 Warnings Exact identifier application number: M021 Parodontax Gum Strengthen and Protect STANNOUS FLUORIDE Haleon US Holdings LLC 3bb40ceb-841b-4a25-e063-6294a90ab897 2025-12-15 Warnings Exact identifier application number: M021 Sensodyne Pronamel Kids Bubble Mint SODIUM FLUORIDE Haleon US Holdings LLC 41b1e626-e79b-d638-e063-6394a90a1f5b 2025-12-15 Warnings Exact identifier application number: M021 Simple Truth Kids Flouride SODIUM MONOFLUOROPHOSPHATE Kroger Company 82b9db89-d108-3f64-e053-2991aa0aee74 2025-12-15 Warnings Exact identifier application number: M021 Natural Adult Fluoride SODIUM MONOFLUOROPHOSPHATE Kroger a71c537e-39d9-1c3b-e053-2a95a90ac3ec 2025-12-15 Warnings Exact identifier application number: M021 Therabreath Overnight Chamomile Mint SODIUM FLUORIDE Church & Dwight Co., Inc. cc0c533c-145e-4877-b421-1baf3a3a572e 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188d28f9-a814-0f98-e063-6294a90a106b 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b4cf935-38a6-f4fb-e063-6394a90a4bc0 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188cddb2-c799-0897-e063-6294a90a5d96 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba491f4-2ad2-6e7b-e063-6394a90a9fb7 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188ac743-3ba8-4da4-e063-6294a90a8f87 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b682604-c563-01f1-e063-6294a90ab0bd 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b110db1-fcc0-377f-e063-6394a90a4d44 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74ecc4-a1e6-348f-e063-6294a90a5894 2025-12-11 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 85162-003-07 85162000307 72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE 72 tube 2025-01-16 No No Current