NDC 59883-018

PerioRestore

Hydrogen Peroxide

PerioRestore is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Den-mat Holdings, Llc.. The primary component is Hydrogen Peroxide.

Product ID59883-018_97a07c36-1af9-a636-e053-2a95a90ad6db
NDC59883-018
Product TypeHuman Otc Drug
Proprietary NamePerioRestore
Generic NameHydrogen Peroxide
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2019-07-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameDEN-MAT HOLDINGS, LLC.
Substance NameHYDROGEN PEROXIDE
Active Ingredient Strength17 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59883-018-87

1 TUBE in 1 BOX (59883-018-87) > 85 g in 1 TUBE
Marketing Start Date2019-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59883-018-87 [59883001887]

PerioRestore GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-15

Drug Details

Active Ingredients

IngredientStrength
HYDROGEN PEROXIDE17 mg/g

NDC Crossover Matching brand name "PerioRestore" or generic name "Hydrogen Peroxide"

NDCBrand NameGeneric Name
59883-018PerioRestorePerioRestore
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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