NDC 55346-0401

Home Care Fluoride

Stannous Fluoride

Home Care Fluoride is a Dental; Oral Gel in the Human Otc Drug category. It is labeled and distributed by Dental Technologies, Inc.. The primary component is Stannous Fluoride.

Product ID55346-0401_7aba579b-a544-ab1e-e053-2a91aa0a56bc
NDC55346-0401
Product TypeHuman Otc Drug
Proprietary NameHome Care Fluoride
Generic NameStannous Fluoride
Dosage FormGel
Route of AdministrationDENTAL; ORAL
Marketing Start Date1999-12-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDental Technologies, Inc.
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength1 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55346-0401-1

121.9 g in 1 TUBE (55346-0401-1)
Marketing Start Date1999-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55346-0401-1 [55346040101]

Home Care Fluoride GEL
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-12-31

NDC 55346-0401-2 [55346040102]

Home Care Fluoride GEL
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-12-31
Marketing End Date2013-05-17

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.969 mg/g

OpenFDA Data

SPL SET ID:15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75
Manufacturer
UNII

NDC Crossover Matching brand name "Home Care Fluoride" or generic name "Stannous Fluoride"

NDCBrand NameGeneric Name
55346-0408Home Care FluorideHome Care Fluoride
55346-0404Home Care FluorideHome Care Fluoride
55346-0401Home Care FluorideHome Care Fluoride
55346-0402Home Care FluorideHome Care Fluoride
0126-0165Gel-Kam Fruit and BerryStannous Fluoride
0126-0192Gel-Kam MintStannous Fluoride
0135-0598parodontaxstannous fluoride
0135-0599parodontaxstannous fluoride
0135-0601parodontaxstannous fluoride
0135-0547SENSODYNEstannous fluoride
0135-0548SENSODYNEstannous fluoride
0135-0575SENSODYNEstannous fluoride
0135-0621SENSODYNEstannous fluoride
0135-0622SENSODYNEstannous fluoride
0135-0572Sensodyne Complete Protectionstannous fluoride
0135-0573Sensodyne Complete Protectionstannous fluoride
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