70766-012 NDC - PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH ()

Drug Information

  • Product NDC: 70766-012
  • Proprietary Name: Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Yangzhou SION Commodity Co.,Ltd
Product Type:
FDA Application Number: M005
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:1/4/2024

Package Information

No. Package Code Package Description Billing Unit
170766-012-01144 TUBE in 1 BOX (70766-012-01) / 24 g in 1 TUBE
270766-012-025 BOX in 1 CARTON (70766-012-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE
370766-012-03144 TUBE in 1 BOX (70766-012-03) / 50 g in 1 TUBE
470766-012-0472 TUBE in 1 BOX (70766-012-04) / 100 g in 1 TUBE
570766-012-05144 TUBE in 1 BOX (70766-012-05) / 100 g in 1 TUBE
670766-012-06480 TUBE in 1 BOX (70766-012-06) / 28 g in 1 TUBE
770766-012-0772 TUBE in 1 BOX (70766-012-07) / 120 g in 1 TUBE
870766-012-08144 TUBE in 1 BOX (70766-012-08) / 120 g in 1 TUBE
970766-012-0912 TUBE in 1 BOX (70766-012-09) / 119 g in 1 TUBE
1070766-012-1072 BOX in 1 CARTON (70766-012-10) / 12 TUBE in 1 BOX / 119 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC70766-012The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEPlak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/4/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM005This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEYangzhou SION Commodity Co.,LtdName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 1/2/2026

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