NDC 53050-002

G.U.M

Sodium Fluoride,cetylpyridinium Chloride

G.U.M is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Sunstar Guangzhou Ltd.. The primary component is Cetylpyridinium Chloride; Sodium Fluoride.

Product ID53050-002_4b537e5c-3680-17d3-e054-00144ff88e88
NDC53050-002
Product TypeHuman Otc Drug
Proprietary NameG.U.M
Generic NameSodium Fluoride,cetylpyridinium Chloride
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2016-07-10
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameSunstar Guangzhou Ltd.
Substance NameCETYLPYRIDINIUM CHLORIDE; SODIUM FLUORIDE
Active Ingredient Strength1 g/100g; g/100g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53050-002-03

9 g in 1 TUBE (53050-002-03)
Marketing Start Date2017-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53050-002-01 [53050000201]

G.U.M PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-23
Marketing End Date2021-01-15

NDC 53050-002-03 [53050000203]

G.U.M PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-23
Marketing End Date2020-02-28

NDC 53050-002-02 [53050000202]

G.U.M PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-23
Marketing End Date2020-02-28

NDC 53050-002-04 [53050000204]

G.U.M PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-23
Marketing End Date2020-02-28

Drug Details

Active Ingredients

IngredientStrength
CETYLPYRIDINIUM CHLORIDE.5 g/100g

OpenFDA Data

SPL SET ID:4b537e5c-367f-17d3-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1875468

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