NDC 37808-993 Heb Hemorrhoidal Cooling Gel

Witch Hazel And Phenylephrine Hydrochloride Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
37808-993
Proprietary Name:
Heb Hemorrhoidal Cooling Gel
Non-Proprietary Name: [1]
Witch Hazel And Phenylephrine Hydrochloride
Substance Name: [2]
Phenylephrine Hydrochloride; Witch Hazel
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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]
    Heb
    Labeler Code:
    37808
    FDA Application Number: [6]
    part346
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    10-18-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 37808-993-24

    Package Description: 1 TUBE in 1 CARTON / 26 g in 1 TUBE

    Product Details

    What is NDC 37808-993?

    The NDC code 37808-993 is assigned by the FDA to the product Heb Hemorrhoidal Cooling Gel which is a human over the counter drug product labeled by Heb. The generic name of Heb Hemorrhoidal Cooling Gel is witch hazel and phenylephrine hydrochloride. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 37808-993-24 1 tube in 1 carton / 26 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 Heb Hemorrhoidal Cooling Gel?

    Adultswhen practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gelapply externally to affected area up to 4 times daily or after each bowel movementChildren under 12 years old: Ask a doctor

    What are Heb Hemorrhoidal Cooling Gel 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 Heb Hemorrhoidal Cooling Gel UNII Codes?

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

    Which are Heb Hemorrhoidal Cooling Gel 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:

    What is the NDC to RxNorm Crosswalk for Heb Hemorrhoidal Cooling Gel?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 249465 - phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel
    • RxCUI: 249465 - phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel
    • RxCUI: 249465 - phenylephrine 0.25 % / witch hazel 50 % Rectal Gel

    Which are the Pharmacologic Classes for Heb Hemorrhoidal Cooling Gel?

    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".