NDC 71042-004 Curoxen Oral Care

Olive Extract,Calendula,Clove Oil Ointment Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
71042-004
Proprietary Name:
Curoxen Oral Care
Non-Proprietary Name: [1]
Olive Extract, Calendula, Clove Oil
Substance Name: [2]
Calendula Officinalis Flowering Top; Clove Oil; Olea Europaea Fruit Volatile Oil
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Organicare Nature's Science, Llc
    Labeler Code:
    71042
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    12-20-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 71042-004-12

    Package Description: 1 TUBE in 1 CARTON / 12 g in 1 TUBE

    Product Details

    What is NDC 71042-004?

    The NDC code 71042-004 is assigned by the FDA to the product Curoxen Oral Care which is a human over the counter drug product labeled by Organicare Nature's Science, Llc. The generic name of Curoxen Oral Care is olive extract, calendula, clove oil. The product's dosage form is ointment and is administered via topical form. The product is distributed in a single package with assigned NDC code 71042-004-12 1 tube in 1 carton / 12 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Curoxen Oral Care?

    Usesfor the temporary relief of pain and to help prevent infection and promote healing of:canker sorescold soresfever blistersminor irritation, injury, cuts or other sores of the mouth and gums.

    What are Curoxen Oral Care Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Curoxen Oral Care UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • CLOVE OIL (UNII: 578389D6D0)
    • CLOVE OIL (UNII: 578389D6D0) (Active Moiety)
    • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
    • OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (Active Moiety)
    • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
    • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)

    Which are Curoxen Oral Care Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".