plak smacker great white shark cool berry flavor anti cavity fluoride gel tooth

Generic: sodium fluoride

Labeler: yangzhou one & only personal care products co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name plak smacker great white shark cool berry flavor anti cavity fluoride gel tooth
Generic Name sodium fluoride
Labeler yangzhou one & only personal care products co., ltd
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium fluoride .1 g/100g

Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co., LTD

Identifiers & Regulatory

Product NDC 85162-003
Product ID 85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-01-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85162003
Hyphenated Format 85162-003

Supplemental Identifiers

RxCUI
416783
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name plak smacker great white shark cool berry flavor anti cavity fluoride gel tooth (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .1 g/100g
source: ndc
Packaging
  • 144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE
  • 5 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE
  • 72 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE
  • 480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE
  • 72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE
  • 144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE
source: ndc

Packages (8)

85162-003-01 144 TUBE in 1 BOX (85162-003-01) / 24 g in 1 TUBE 85162-003-02 5 BOX in 1 CARTON (85162-003-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE 85162-003-03 144 TUBE in 1 BOX (85162-003-03) / 50 g in 1 TUBE 85162-003-04 72 TUBE in 1 BOX (85162-003-04) / 100 g in 1 TUBE 85162-003-05 144 TUBE in 1 BOX (85162-003-05) / 100 g in 1 TUBE 85162-003-06 480 TUBE in 1 BOX (85162-003-06) / 28 g in 1 TUBE 85162-003-07 72 TUBE in 1 BOX (85162-003-07) / 120 g in 1 TUBE 85162-003-08 144 TUBE in 1 BOX (85162-003-08) / 120 g in 1 TUBE

Ingredients (1)

sodium fluoride (.1 g/100g)

Linked Drug Pages (1)

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2bce1352-ed26-a13d-e063-6394a90a2d08", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["bb93fb1a-885a-4d2a-a1c2-3b37bc305d57"], "manufacturer_name": ["Yangzhou ONE & ONLY Personal Care Products Co., LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 TUBE in 1 BOX (85162-003-01)  / 24 g in 1 TUBE", "package_ndc": "85162-003-01", "marketing_start_date": "20250116"}, {"sample": false, "description": "5 BOX in 1 CARTON (85162-003-02)  / 24 TUBE in 1 BOX / 28 g in 1 TUBE", "package_ndc": "85162-003-02", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-003-03)  / 50 g in 1 TUBE", "package_ndc": "85162-003-03", "marketing_start_date": "20250116"}, {"sample": false, "description": "72 TUBE in 1 BOX (85162-003-04)  / 100 g in 1 TUBE", "package_ndc": "85162-003-04", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-003-05)  / 100 g in 1 TUBE", "package_ndc": "85162-003-05", "marketing_start_date": "20250116"}, {"sample": false, "description": "480 TUBE in 1 BOX (85162-003-06)  / 28 g in 1 TUBE", "package_ndc": "85162-003-06", "marketing_start_date": "20250116"}, {"sample": false, "description": "72 TUBE in 1 BOX (85162-003-07)  / 120 g in 1 TUBE", "package_ndc": "85162-003-07", "marketing_start_date": "20250116"}, {"sample": false, "description": "144 TUBE in 1 BOX (85162-003-08)  / 120 g in 1 TUBE", "package_ndc": "85162-003-08", "marketing_start_date": "20250116"}], "brand_name": "Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth", "product_id": "85162-003_2bce1352-ed26-a13d-e063-6394a90a2d08", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "85162-003", "generic_name": "SODIUM FLUORIDE", "labeler_name": "Yangzhou ONE & ONLY Personal Care Products Co., LTD", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".1 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250116", "listing_expiration_date": "20261231"}