NDC 62864-760

Orajel Antiseptic Rinse For All Mouth Sores

Hydrogen Peroxide 1.5%, Menthol 0.1%

Orajel Antiseptic Rinse For All Mouth Sores is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Canada Corp.. The primary component is Hydrogen Peroxide; Menthol.

Product ID62864-760_0618c1d8-5c91-1e88-e054-00144ff8d46c
NDC62864-760
Product TypeHuman Otc Drug
Proprietary NameOrajel Antiseptic Rinse For All Mouth Sores
Generic NameHydrogen Peroxide 1.5%, Menthol 0.1%
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch & Dwight Canada Corp.
Substance NameHYDROGEN PEROXIDE; MENTHOL
Active Ingredient Strength2 mL/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62864-760-16

473.2 mL in 1 BOTTLE (62864-760-16)
Marketing Start Date2014-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62864-760-16 [62864076016]

Orajel Antiseptic Rinse For All Mouth Sores LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-11-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROGEN PEROXIDE1.5 mL/mL

OpenFDA Data

SPL SET ID:0618c1d8-5c8f-1e88-e054-00144ff8d46c
Manufacturer
UNII

NDC Crossover Matching brand name "Orajel Antiseptic Rinse For All Mouth Sores" or generic name "Hydrogen Peroxide 1.5%, Menthol 0.1%"

NDCBrand NameGeneric Name
10237-759Orajel Alcohol Free Antiseptic RinseHydrogen Peroxide 1.5%, Menthol 0.1%
62864-759Orajel Alcohol Free Antiseptic RinseHydrogen Peroxide 1.5%, Menthol 0.1%
10237-760Orajel Antiseptic RinseHydrogen Peroxide 1.5%, Menthol 0.1%
62864-760Orajel Antiseptic RinseHydrogen Peroxide 1.5%, Menthol 0.1%

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.