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 35 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Target Kids Watermelon Mint SODIUM FLUORIDE Target 35bc2e4d-f1c7-438e-e063-6394a90aead0 2025-10-17 Warnings Exact identifier application number: M021 MediChoice Fluoride SODIUM MONOFLUOROPHOSPHATE O&M HALYARD, INC. a87956fa-8975-4a44-9e9a-4b2191e401fe 2025-10-09 Warnings Exact identifier application number: M021 BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b6f893d-74ac-421e-a78b-f495ac425af0 2025-10-09 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. a3e989f8-e6a2-4e13-8faa-77e95895166d 2025-10-09 Warnings Exact identifier application number: M021 TARGET UP AND UP ANTICAVITY SODIUM FLUORIDE 0.05% TARGET CORPORATION 2992efce-1c66-df40-e063-6294a90ab3c0 2025-10-08 Warnings Exact identifier application number: M021 MediChoice Premium Anticavity Fluoride SODIUM FLUORIDE O&M HALYARD, INC. c6ba9b51-b958-4836-adc8-871529a43fc6 2025-10-08 Warnings Exact identifier application number: M021 Tidalove SPICY CINNAMON TOOTHPASTE TABLETS Paranmare LLC 4092fcbf-27f7-b067-e063-6394a90a41c6 2025-10-07 Warnings Exact identifier application number: M021 Tidalove COOL MINT TOOTHPASTE TABLETS Paranmare LLC 4093060c-23a5-c77a-e063-6394a90a9304 2025-10-07 Warnings Exact identifier application number: M021 Tidalove YUZU MINT TOOTHPASTE TABLETS Paranmare LLC 40946943-21cf-b114-e063-6394a90aed3f 2025-10-07 Warnings Exact identifier application number: M021 Optimax Purple Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC fdb16e59-5be1-4bd0-a940-d542d67fb2df 2025-10-02 Warnings Exact identifier application number: M021 Intensive Enamel Repair Whitening TP INTENSIVE ENAMEL REPAIR WHITENING TP Topco Associates LLC 3012a8da-7595-2f7c-e063-6294a90ae120 2025-09-30 Warnings Exact identifier application number: M021 Made by Dentists For Kids Eyeball Juice (Watermelon) SODIUM FLUORIDE MADE BY DENTISTS INC b2ad2b19-6fdf-454d-9b1d-49b1c81016fd 2025-09-30 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. a38363e6-7105-4663-95a0-09ecb2948f83 2025-09-30 Warnings Exact identifier application number: M021 UNPA CHA CHA TOOTHPASTE SODIUM MONOFLUOROPHOSPHATE DONG IL PHARMS CO.,LTD 3fae966e-0246-b9f2-e063-6394a90a494c 2025-09-26 Warnings Exact identifier application number: M021 Cloveden Tooth SODIUM MONOFLUOROPHOSPHATE DONG IL PHARMS CO.,LTD 3fb01bea-7205-49ba-e063-6294a90a3841 2025-09-26 Warnings Exact identifier application number: M021 Cloveden Sensitive Care Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 3fb153f1-ba6e-7251-e063-6294a90abe62 2025-09-26 Warnings Exact identifier application number: M021 Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE DONG IL PHARMS CO.,LTD 3fb1a2ee-381e-a9e8-e063-6394a90a864b 2025-09-26 Warnings Exact identifier application number: M021 unpa Cha Cha Toothpaste SODIUM MONOFLUOROPHOSPHATE Lycl Inc. 230b3cf2-053a-4e8b-8d50-05bbc877faa8 2025-09-25 Warnings Exact identifier application number: M021 TheraBreath Anticavity SODIUM FLUORIDE Church & Dwight Co., Inc. 3c5d58f1-ea8c-4708-bbc6-21e1cd1446da 2025-09-19 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1 2025-09-18 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