NDC 60319-1001

Premium Whitening

Hydrogen Peroxide

Premium Whitening is a Dental Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Hankuk Bowonbio Co., Ltd. The primary component is Hydrogen Peroxide.

Product ID60319-1001_95ed2181-d9d7-42cc-9658-660ff7a91d19
NDC60319-1001
Product TypeHuman Otc Drug
Proprietary NamePremium Whitening
Generic NameHydrogen Peroxide
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date2011-09-13
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameHankuk Bowonbio Co., Ltd
Substance NameHYDROGEN PEROXIDE
Active Ingredient Strength35 mL/100mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 60319-1001-1

4.3 mL in 1 BOTTLE, PLASTIC (60319-1001-1)
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60319-1001-1 [60319100101]

Premium Whitening GEL, DENTIFRICE
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
HYDROGEN PEROXIDE35 mL/100mL

OpenFDA Data

SPL SET ID:77d048e9-6f92-486b-b65b-b5a8e5ac3a35
Manufacturer
UNII

NDC Crossover Matching brand name "Premium Whitening" or generic name "Hydrogen Peroxide"

NDCBrand NameGeneric Name
60319-1001Premium WhiteningPremium Whitening
0924-0171First Aid Only Hydrogen PeroxideHydrogen Peroxide
0363-0267Hydrogen PeroxideHydrogen Peroxide
0363-0268Hydrogen PeroxideHydrogen Peroxide
0363-0871Hydrogen PeroxideHYDROGEN PEROXIDE
0404-0001Hydrogen PeroxideHydrogen Peroxide
0869-0871Hydrogen PeroxideHYDROGEN PEROXIDE
10202-001Hydrogen PeroxideHydrogen Peroxide
0924-0932Hydrogen Peroxide AntisepticHydrogen Peroxide
10031-008MedPak Peroxide Oral RinseHYDROGEN PEROXIDE
0126-0083Peroxyl Mouth Sore Mild MintHydrogen Peroxide
0363-0085Sore Mouth CleanserHydrogen Peroxide
0869-0462Sore Mouth CleanserHydrogen Peroxide
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