NDC 55758-001 Doloear

Atropa Belladonna,Apis Mellifera,Aristolochia Clematitis Root,Matricaria Recutita,Lachesis - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
55758-001
Proprietary Name:
Doloear
Non-Proprietary Name: [1]
Atropa Belladonna, Apis Mellifera, Aristolochia Clematitis Root, Matricaria Recutita, Lachesis Muta Venom, And Thuja Occidentalis Leafy Twig
Substance Name: [2]
Apis Mellifera; Aristolochia Clematitis Root; Atropa Belladonna; Lachesis Muta Venom; Matricaria Recutita; Thuja Occidentalis Leafy Twig
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Auricular (otic) - Administration to or by way of the ear.
  • Labeler Name: [5]
    Pharmadel Llc
    Labeler Code:
    55758
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    05-23-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 55758-001-15

    Package Description: 15 mL in 1 BOTTLE, DROPPER

    Product Details

    What is NDC 55758-001?

    The NDC code 55758-001 is assigned by the FDA to the product Doloear which is a human over the counter drug product labeled by Pharmadel Llc. The generic name of Doloear is atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja occidentalis leafy twig. The product's dosage form is solution/ drops and is administered via auricular (otic) form. The product is distributed in a single package with assigned NDC code 55758-001-15 15 ml in 1 bottle, dropper . 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 Doloear?

    Adults and children: Remove tamper-evident neckband from bottle. Shake bottle before each use. Tilt head sideways and apply 2-3 drops into ear (to preserve purity, prevent tip of dropper from touching ear.) Allow drops to remain in ear by keeping head tilted or placing cotton in ear. Repeat as needed.

    What are Doloear 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 Doloear UNII Codes?

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

    Which are Doloear 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:

    Which are the Pharmacologic Classes for Doloear?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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".