NDC 61578-301

CTx3 Rinse Mint

Anticaries

CTx3 Rinse Mint is a Dental Rinse in the Human Otc Drug category. It is labeled and distributed by Oral Biotech. The primary component is Sodium Fluoride.

Product ID61578-301_16ba2e79-b217-44b5-b228-76507e06eb12
NDC61578-301
Product TypeHuman Otc Drug
Proprietary NameCTx3 Rinse Mint
Generic NameAnticaries
Dosage FormRinse
Route of AdministrationDENTAL
Marketing Start Date2012-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart355
Labeler NameOral BioTech
Substance NameSODIUM FLUORIDE
Active Ingredient Strength226 ug/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61578-301-01

473 mL in 1 BOTTLE, PLASTIC (61578-301-01)
Marketing Start Date2012-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61578-301-02 [61578030102]

CTx3 Rinse Mint RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-01
Inactivation Date2019-11-27

NDC 61578-301-01 [61578030101]

CTx3 Rinse Mint RINSE
Marketing CategoryOTC monograph final
Application Numberpart355
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE226 ug/mL

OpenFDA Data

SPL SET ID:aa61834a-ff12-4c31-828f-43b1292fef3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1486534
  • 240698
  • NDC Crossover Matching brand name "CTx3 Rinse Mint" or generic name "Anticaries"

    NDCBrand NameGeneric Name
    61578-301CTx3 RinseAnticaries
    61578-302CTx3 RinseAnticaries
    61578-303CTx3 RinseAnticaries
    61578-304CTx4 RinseAnticaries
    61578-305CTx4 RinseAnticaries
    61578-311Maintenance RinseAnticaries
    61578-312Maintenance RinseAnticaries
    61578-313Maintenance RinseAnticaries
    61578-314Treatment RinseAnticaries
    61578-315Treatment RinseAnticaries

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