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NDC 0904-6977 Hemorrhoidal

Hard Fat,Phenylephrine Hcl Suppository Rectal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0904-6977?
  4. Hemorrhoidal Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
0904-6977
Proprietary Name:
Hemorrhoidal
Non-Proprietary Name: [1]
Hard Fat, Phenylephrine Hcl
Substance Name: [2]
Hard Fat; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route(s): [4]
  • Rectal - Administration to the rectum.
    • Labeler Name: [5]
    Major Pharmaceuticals
    Labeler Code:
    0904
    Product Label ID:
    99fcda73-472f-d5fe-e053-2995a90a9fa4
    FDA Application Number: [6]
    M015
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    12-18-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0904-6977-12

    Package Description: 2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK

    Product Details

    What is NDC 0904-6977?

    The NDC code 0904-6977 is assigned by the FDA to the product Hemorrhoidal which is a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Hemorrhoidal is hard fat, phenylephrine hcl. The product's dosage form is suppository and is administered via rectal form. The product is distributed in a single package with assigned NDC code 0904-6977-12 2 blister pack in 1 carton / 6 suppository in 1 blister pack. 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 Hemorrhoidal?

    When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.detach on suppository from the stripseparate the two tabs of the white plastic wrapwith thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppositoryinsert one suppository into the rectumadults and children 12 years and over: insert one suppository rectally up to 4 times daily children under 12 years: ask a doctor

    What are Hemorrhoidal 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 Hemorrhoidal UNII Codes?

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

    Which are Hemorrhoidal 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 Hemorrhoidal?

    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.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [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".