NDC 0869-0462

Sore Mouth Cleanser

Hydrogen Peroxide

Sore Mouth Cleanser is a Topical Mouthwash in the Human Otc Drug category. It is labeled and distributed by Vi-jon. The primary component is Hydrogen Peroxide.

Product ID0869-0462_1b7045aa-e304-409f-bc81-743cabdb145b
NDC0869-0462
Product TypeHuman Otc Drug
Proprietary NameSore Mouth Cleanser
Generic NameHydrogen Peroxide
Dosage FormMouthwash
Route of AdministrationTOPICAL
Marketing Start Date2017-05-02
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameVi-Jon
Substance NameHYDROGEN PEROXIDE
Active Ingredient Strength1588 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0869-0462-34

236 mL in 1 BOTTLE, PLASTIC (0869-0462-34)
Marketing Start Date2017-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0869-0462-34 [00869046234]

Sore Mouth Cleanser MOUTHWASH
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-02

Drug Details

Active Ingredients

IngredientStrength
HYDROGEN PEROXIDE1588 mg/mL

OpenFDA Data

SPL SET ID:2eb9062f-0944-4730-838a-2dddcb79332c
Manufacturer
UNII

NDC Crossover Matching brand name "Sore Mouth Cleanser" or generic name "Hydrogen Peroxide"

NDCBrand NameGeneric Name
0363-0085Sore Mouth CleanserHydrogen Peroxide
0869-0462Sore Mouth CleanserHydrogen Peroxide
69842-008Sore Mouth CleanserSore Mouth Cleanser
41250-750Sore Mouth CleanserSore Mouth Cleanser
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

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