NDC 49410-200

teeth desensitizing and remineralizing gel

Potassium Nitrate,sodium Fluoride,sodium Monofluorophosphate

teeth desensitizing and remineralizing gel is a Dental Paste in the Human Otc Drug category. It is labeled and distributed by Fuzhou Difeng Bio-tech Co., Ltd.. The primary component is Potassium Nitrate; Sodium Fluoride.

Product ID49410-200_62180c5e-1369-1c60-e053-2a91aa0a3668
NDC49410-200
Product TypeHuman Otc Drug
Proprietary Nameteeth desensitizing and remineralizing gel
Generic NamePotassium Nitrate,sodium Fluoride,sodium Monofluorophosphate
Dosage FormPaste
Route of AdministrationDENTAL
Marketing Start Date2016-03-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameFuzhou Difeng Bio-tech Co., Ltd.
Substance NamePOTASSIUM NITRATE; SODIUM FLUORIDE
Active Ingredient Strength50 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49410-200-01

5 CONTAINER in 1 CARTON (49410-200-01) > 200 VIAL, SINGLE-USE in 1 CONTAINER > 1.5 g in 1 VIAL, SINGLE-USE
Marketing Start Date2018-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49410-200-08 [49410020008]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-06 [49410020006]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-02 [49410020002]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-01 [49410020001]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-04 [49410020004]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-07 [49410020007]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-03 [49410020003]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

NDC 49410-200-05 [49410020005]

teeth desensitizing and remineralizing gel PASTE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
POTASSIUM NITRATE50 mg/g

OpenFDA Data

SPL SET ID:2d4e6542-faa9-63f2-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1038841

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