FDA.reportPublic FDA data

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

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
IngredientStrength
SODIUM FLUORIDE.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85162-003-01Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441
85162-003-01Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth24 g in 1 TUBEPASTE, DENTIFRICE241
85162-003-02Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth24 in 1 BOXPASTE, DENTIFRICE241
85162-003-02Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth5 in 1 CARTONPASTE, DENTIFRICE51
85162-003-03Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth50 g in 1 TUBEPASTE, DENTIFRICE501
85162-003-03Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441
85162-003-04Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
85162-003-04Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 BOXPASTE, DENTIFRICE721
85162-003-05Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
85162-003-05Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441
85162-003-06Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth28 g in 1 TUBEPASTE, DENTIFRICE281
85162-003-06Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth480 in 1 BOXPASTE, DENTIFRICE4801
85162-003-07Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 BOXPASTE, DENTIFRICE721
85162-003-07Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
85162-003-08Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
85162-003-08Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85162-003PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]1Current NDC, 16 package rows20250117_bb93fb1a-885a-4d2a-a1c2-3b37bc305d57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYbb93fb1a-885a-4d2a-a1c2-3b37bc305d571
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYbb93fb1a-885a-4d2a-a1c2-3b37bc305d571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85162-003-0185162000301144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-003-02851620003025 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE5 box2025-01-16NoNoCurrent
85162-003-0385162000303144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-003-048516200030472 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE72 tube2025-01-16NoNoCurrent
85162-003-0585162000305144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE144 tube2025-01-16NoNoCurrent
85162-003-0685162000306480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE480 tube2025-01-16NoNoCurrent
85162-003-078516200030772 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE72 tube2025-01-16NoNoCurrent
85162-003-0885162000308144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE144 tube2025-01-16NoNoCurrent