NDC 81577-6000

Orak-100

Hydrogen Peroxide

Orak-100 is a Buccal Solution in the Human Otc Drug category. It is labeled and distributed by Joaquin Armando Cardenas Urquidez. The primary component is Hydrogen Peroxide; Hypochlorous Acid; Sodium Hypochlorite.

Product ID81577-6000_bd3d5b31-2f81-3717-e053-2995a90a93c3
NDC81577-6000
Product TypeHuman Otc Drug
Proprietary NameOrak-100
Generic NameHydrogen Peroxide
Dosage FormSolution
Route of AdministrationBUCCAL
Marketing Start Date2021-03-10
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart333A
Labeler NameJOAQUIN ARMANDO CARDENAS URQUIDEZ
Substance NameHYDROGEN PEROXIDE; HYPOCHLOROUS ACID; SODIUM HYPOCHLORITE
Active Ingredient Strength0 mL/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 81577-6000-6

240 mL in 1 BOTTLE (81577-6000-6)
Marketing Start Date2021-03-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Orak-100" or generic name "Hydrogen Peroxide"

NDCBrand NameGeneric Name
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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