NDC 55316-318

Antiseptic

Eucalyptol, Menthol, Methyl Salicylate, Thymol

Antiseptic is a Oral Rinse in the Human Otc Drug category. It is labeled and distributed by Dza Brands, Llc. The primary component is Eucalyptol; Menthol; Methyl Salicylate; Thymol.

Product ID55316-318_57b18499-74e0-430e-a6a1-8119673818ae
NDC55316-318
Product TypeHuman Otc Drug
Proprietary NameAntiseptic
Generic NameEucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage FormRinse
Route of AdministrationORAL
Marketing Start Date2008-02-05
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameDZA Brands, LLC
Substance NameEUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active Ingredient Strength1 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55316-318-69

250 mL in 1 BOTTLE, PLASTIC (55316-318-69)
Marketing Start Date2008-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-318-69 [55316031869]

Antiseptic RINSE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-02-05

NDC 55316-318-86 [55316031886]

Antiseptic RINSE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-02-05

Drug Details

Active Ingredients

IngredientStrength
EUCALYPTOL.92 mg/mL

OpenFDA Data

SPL SET ID:854085b3-3307-4f54-9d36-00b6fbb061c2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043619
  • NDC Crossover Matching brand name "Antiseptic" or generic name "Eucalyptol, Menthol, Methyl Salicylate, Thymol"

    NDCBrand NameGeneric Name
    0363-7110Antisepticbenzalkonium chloride
    0498-0402AntisepticBenzalkonium chloride
    0869-0072AntisepticEucalyptol, Menthol, Methyl salicylate, thymol
    0869-0299AntisepticCETYLPYRIDINIUM CHLORIDE
    68421-7120AntisepticAntiseptic
    68599-5322AntisepticAntiseptic
    71310-006AntisepticAntiseptic
    71622-001AntisepticAntiseptic
    75981-318AntisepticAntiseptic
    72663-111AntisepticAntiseptic
    75981-299AntisepticAntiseptic
    0924-7110AntisepticAntiseptic
    11673-299AntisepticAntiseptic
    11673-318AntisepticAntiseptic
    33992-0072AntisepticAntiseptic
    36800-299AntisepticAntiseptic
    37012-299AntisepticAntiseptic
    37205-664AntisepticAntiseptic
    37012-318AntisepticAntiseptic
    41250-072AntisepticAntiseptic
    41190-299AntisepticAntiseptic
    42507-299AntisepticAntiseptic
    42507-318AntisepticAntiseptic
    47682-306AntisepticAntiseptic
    47682-316AntisepticAntiseptic
    47682-245AntisepticAntiseptic
    47682-214AntisepticAntiseptic
    47682-302AntisepticAntiseptic
    47682-215AntisepticAntiseptic
    49035-299AntisepticAntiseptic
    49035-318AntisepticAntiseptic
    49348-482AntisepticAntiseptic
    49348-480AntisepticAntiseptic
    50804-299AntisepticAntiseptic
    50804-318AntisepticAntiseptic
    51143-210AntisepticAntiseptic
    51532-5300AntisepticAntiseptic
    51143-299AntisepticAntiseptic
    51532-5301AntisepticAntiseptic
    51718-3112AntisepticAntiseptic
    51718-3111AntisepticAntiseptic
    52116-7100AntisepticAntiseptic
    52124-0001AntisepticAntiseptic
    52641-700AntisepticAntiseptic
    55316-318AntisepticAntiseptic
    55301-318AntisepticAntiseptic
    55301-210AntisepticAntiseptic
    55301-299AntisepticAntiseptic
    55319-299AntisepticAntiseptic
    0869-0318Antiseptic Mouth RinseEUCALYPTOL, Menthol, Methyl salicylate, Thymol

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