NDC 53045-275

Ionite H

Stannous Fluoride

Ionite H is a Dental Mouthwash in the Human Otc Drug category. It is labeled and distributed by Dharma Research, Inc.. The primary component is Stannous Fluoride.

Product ID53045-275_bb9fa14d-082b-4773-8836-1c6736219ff2
NDC53045-275
Product TypeHuman Otc Drug
Proprietary NameIonite H
Generic NameStannous Fluoride
Dosage FormMouthwash
Route of AdministrationDENTAL
Marketing Start Date2015-08-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDharma Research, Inc.
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength1 mg/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53045-275-10

296 mL in 1 BOTTLE, DISPENSING (53045-275-10)
Marketing Start Date2015-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-275-10 [53045027510]

Ionite H MOUTHWASH
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-03

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.63 mg/100mL

OpenFDA Data

SPL SET ID:5c312b36-07f4-406e-b3d3-c6d1e964635d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 583459
    • UPC Code
  • 0353045000994

    • NDC Crossover Matching brand name "Ionite H" or generic name "Stannous Fluoride"

    NDCBrand NameGeneric Name
    53045-276Ionite HIonite H
    53045-281Ionite HIonite H
    53045-270Ionite HIonite H
    53045-275Ionite HIonite H
    53045-271Ionite HIonite H
    53045-280Ionite HIonite H
    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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