NDC 50438-304

Royal Mouthwash Fresh and Clean Original Mint

Eucalyptol, Menthol, Methyl Salicylate, Thymol

Royal Mouthwash Fresh and Clean Original Mint is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Filo America. The primary component is Eucalyptol; Menthol; Methyl Salicylate; Thymol.

Product ID50438-304_1dd6b65e-11df-4ec2-93af-70888a53b1b1
NDC50438-304
Product TypeHuman Otc Drug
Proprietary NameRoyal Mouthwash Fresh and Clean Original Mint
Generic NameEucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-09-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameFilo America
Substance NameEUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active Ingredient Strength1 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50438-304-01

1000 mL in 1 BOTTLE, PLASTIC (50438-304-01)
Marketing Start Date2013-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50438-304-01 [50438030401]

Royal Mouthwash Fresh and Clean Original Mint LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-09-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
EUCALYPTOL.92 mg/mL

OpenFDA Data

SPL SET ID:3830dc3a-98f7-4b56-b3ae-281bb24e2e1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043619
  • NDC Crossover Matching brand name "Royal Mouthwash Fresh and Clean Original Mint" or generic name "Eucalyptol, Menthol, Methyl Salicylate, Thymol"

    NDCBrand NameGeneric Name
    50438-304Royal Mouthwash Fresh and Clean Original MintRoyal Mouthwash Fresh and Clean Original Mint
    0869-0072AntisepticEucalyptol, Menthol, Methyl salicylate, thymol
    0869-0318Antiseptic Mouth RinseEUCALYPTOL, Menthol, Methyl salicylate, Thymol
    0363-0080AntispeticEucalyptol, menthol, methyl salicylate, thymol
    0363-0664AntispeticEucalyptol, menthol, methyl salicylate, thymol
    0869-0664AntispeticEucalyptol, menthol, methyl salicylate, thymol
    10202-664AntispeticEucalyptol, menthol, methyl salicylate, thymol
    11344-567AntispeticEucalyptol, menthol, methyl salicylate, thymol
    11673-072AntispeticEucalyptol, menthol, methyl salicylate, thymol
    0363-0318RinseEucalyptol, menthol, Methyl salicylate, thymol
    0363-0045Tartar Control Pluseucalyptol, menthol, methyl salicylate, thymol
    0363-0434Tartar control plusEucalyptol, menthol, methyl salicylate, thymol
    0363-0855Tartar control plusEucalyptol, menthol, methyl salicylate, thymol
    0869-0434Tartar Control PlusEucalyptol, menthol, methyl salicylate, thymol
    0869-0855Tartar control plusEucalyptol, menthol, methyl salicylate, thymol

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