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 41 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quip Anticavity SODIUM FLUORIDE Quip NYC Inc. b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a 2025-01-30 Warnings Exact identifier application number: M021 Quip SODIUM FLUORIDE Quip NYC Inc. 714b7205-444d-929b-e053-2995a90a958e 2025-01-30 Warnings Exact identifier application number: M021 Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4 2025-01-29 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DOCSMEDI Co., Ltd. ea18ac56-4ef1-4bf0-8c26-6885183fd684 2025-01-22 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DOCSMEDI Co., Ltd. aaf08481-a2ff-48f6-8611-73a469efe1db 2025-01-22 Warnings Exact identifier application number: M021 Double X CONCENTRATED CETYLPYRIDINIUM CHLORIDE DOCSMEDI Co., Ltd. 411be334-364c-4074-8d0b-8dda332f87de 2025-01-22 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude d33e3778-ba1d-4560-bafa-74f7ab88c6b5 2025-01-20 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE gel SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 86279b4d-82e5-45b5-9ba7-94fe3620b850 2025-01-16 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 2025-01-16 Warnings Exact identifier application number: M021 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 2025-01-16 Warnings Exact identifier application number: M021 ndc (product): 85162-003 Medpride SODIUM MONOFLUOROPHOSPHATE Shield Line LLC 9c1b0420-6b57-4914-99fe-df6a494815c3 2025-01-16 Warnings Exact identifier application number: M021 Sodium Fluoride SODIUM FLUORIDE Safco Dental Supply LLC 7a295974-c400-4442-9149-138a805ffb20 2025-01-09 Warnings Exact identifier application number: M021 Salivea FLUORIDE TOOTHPASTE Laclede, Inc. 6398ae96-dd38-44da-bc34-1d4d4c4a78ca 2025-01-08 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 098a29d5-3836-d362-e063-6394a90a9fea 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Sensitivity Care Prebiotic Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Sensitive Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. dec29c9f-6ddb-0b4e-e053-2995a90a64b1 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Original Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8e5de76b-535a-9c95-e053-2995a90afcab 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8f27c88a-7a70-e00a-e053-2a95a90a95a4 2025-01-01 Warnings Exact identifier application number: M021 POP Feeling Peachy SODIUM FLUORIDE TAI GUK PHARM. CO., LTD 0abb7a95-60b1-a1f3-e063-6294a90ace0c 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 99fff177-6300-220e-e053-2a95a90a0660 2025-01-01 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