NDC 58264-0068 D-68

Croton Oil,Daphne Mezereum Bark,Sodium Chloride,And Toxicodendron Pubescens Leaf Solution - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
58264-0068
Proprietary Name:
D-68
Non-Proprietary Name: [1]
Croton Oil, Daphne Mezereum Bark, Sodium Chloride, And Toxicodendron Pubescens Leaf
Substance Name: [2]
Croton Oil; Daphne Mezereum Bark; Sodium Chloride; Toxicodendron Pubescens Leaf
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
  • Labeler Name: [5]
    Labeler Code:
    58264
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    01-01-1990
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 58264-0068?

    The NDC code 58264-0068 is assigned by the FDA to the product D-68 which is a human over the counter drug product labeled by Dna Labs, Inc.. The generic name of D-68 is croton oil, daphne mezereum bark, sodium chloride, and toxicodendron pubescens leaf. The product's dosage form is solution and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 58264-0068-1 29.57 ml in 1 bottle, glass . 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 D-68?

    This product is used as Pustular eruptions.

    What are D-68 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 D-68 UNII Codes?

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

    Which are D-68 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:

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    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".