71167-005 NDC - PLAK SMACKER ANTI-CAVITY FLUORIDE GEL ()

Drug Information

  • Product NDC: 71167-005
  • Proprietary Name: PLAK SMACKER Anti-cavity Fluoride Gel
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: HUAIAN ZONGHENG BIO-TECH CO., LTD
Product Type:
FDA Application Number: part355
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:2/2/2018

Package Information

No. Package Code Package Description Billing Unit
171167-005-01144 TUBE in 1 CARTON (71167-005-01) / 24 g in 1 TUBE
271167-005-02120 BOX in 1 CARTON (71167-005-02) / 24 TUBE in 1 BOX / 28 g in 1 TUBE
371167-005-03120 BOX in 1 CARTON (71167-005-03) / 24 TUBE in 1 BOX / 120 g in 1 TUBE
471167-005-04144 TUBE in 1 CARTON (71167-005-04) / 50 g in 1 TUBE
571167-005-0572 TUBE in 1 CARTON (71167-005-05) / 100 g in 1 TUBE
671167-005-06144 TUBE in 1 BOX (71167-005-06) / 100 g in 1 TUBE
771167-005-07480 TUBE in 1 BOX (71167-005-07) / 28 g in 1 TUBE
871167-005-0872 TUBE in 1 BOX (71167-005-08) / 120 g in 1 TUBE
971167-005-09144 TUBE in 1 BOX (71167-005-09) / 120 g in 1 TUBE
1071167-005-10288 TUBE in 1 BOX (71167-005-10) / 50 g in 1 TUBE
1171167-005-11480 BOX in 1 CARTON (71167-005-11) / 24 TUBE in 1 BOX / 28 g in 1 TUBE
1271167-005-12576 BOX in 1 CARTON (71167-005-12) / 144 TUBE in 1 BOX / 24 g in 1 TUBE
1371167-005-1372 BOX in 1 CARTON (71167-005-13) / 12 TUBE in 1 BOX / 120 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC71167-005The 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 Anti-cavity Fluoride GelThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/2/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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 NUMBERpart355This 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 NAMEHUAIAN ZONGHENG BIO-TECH CO., LTDName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 4/25/2025

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