NDC 53045-271

Ionite H

Stannous Fluoride

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

Product ID53045-271_1f70f58a-266a-4d51-9895-9ac70f8425ec
NDC53045-271
Product TypeHuman Otc Drug
Proprietary NameIonite H
Generic NameStannous Fluoride
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2015-08-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameDharma Research, Inc.
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength0 mg/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53045-271-04

122 g in 1 TUBE (53045-271-04)
Marketing Start Date2015-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-271-04 [53045027104]

Ionite H GEL, DENTIFRICE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-02

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.4 mg/100g

OpenFDA Data

SPL SET ID:042636cf-8b61-4022-b0a1-af09c06b145b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 237847

    • 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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