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 31 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b68315c-6afa-3f37-e063-6294a90a14e8 2025-12-11 Warnings Exact identifier application number: M021 ANTICAVITY FLUORIDE SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 295b88e8-c4b5-c0b0-e063-6394a90aca01 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74f072-c33b-c6e2-e063-6394a90ab1e6 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba4a807-d6d5-04a0-e063-6294a90ae04d 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b617f4a-b56c-9f75-e063-6294a90a7abe 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b9ec370-eadf-92c4-e063-6294a90a9055 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1eb04296-ecb1-3ccc-e063-6294a90a9bda 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b9e7b21-0d34-74ec-e063-6294a90a1f59 2025-12-11 Exact identifier application number: M021 Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash SODIUM FLUORIDE Kenvue Brands LLC 28986d7f-3e9a-8dfb-e063-6394a90a731e 2025-12-10 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Colgate-Palmolive Company 0d6c51bc-5391-4533-b4fd-961dc4f36342 2025-12-10 Warnings Exact identifier application number: M021 Business Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. 483d7aec-34ac-49c5-ac0e-8fba5b4737ae 2025-12-09 Warnings Exact identifier application number: M021 Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 121decce-c364-4060-87da-0c6a6cd48474 2025-12-08 Warnings Exact identifier application number: M021 First Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. ba717de8-c3a2-41bf-85a1-aa75f9744d30 2025-12-08 Warnings Exact identifier application number: M021 United Airlines Business Class Kit SODIUM MONOFLUOROPHOSPHATE United Airlines 94c5e9a4-19f3-4590-9da4-313c75261231 2025-12-08 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 5f08d994-e458-42b2-aa39-e84fca3acf48 2025-12-05 Warnings Exact identifier application number: M021 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
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