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  4. NDC Product Code: 0573-2840 Preparation H Cooling Gel

NDC 0573-2840 Preparation H Cooling Gel

Phenylephrine Hcl,Witch Hazel Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0573-2840?
  4. Preparation H Cooling Gel Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

NDC Product Code:
0573-2840
Proprietary Name:
Preparation H Cooling Gel
Non-Proprietary Name: [1]
Phenylephrine Hcl, Witch Hazel
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:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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]
    Haleon Us Holdings Llc
    Labeler Code:
    0573
    Product Label ID:
    cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4
    FDA Application Number: [6]
    M015
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-01-2004
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0573-2840-10

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

    NDC Code 0573-2840-20

    Package Description: 1 TUBE in 1 CARTON / 51 g in 1 TUBE

    Price per Unit: $0.18081 per GM

    Product Details

    What is NDC 0573-2840?

    The NDC code 0573-2840 is assigned by the FDA to the product Preparation H Cooling Gel which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Preparation H Cooling Gel is phenylephrine hcl, witch hazel. The product's dosage form is gel and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 0573-2840-10 1 tube in 1 carton / 26 g in 1 tube, 0573-2840-20 1 tube in 1 carton / 51 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 Preparation H Cooling Gel?

    Adults: 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 applying gel.when first opening the tube, puncture foil seal with top end of capapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementchildren under 12 years of age: ask a doctor

    What are Preparation H 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 Preparation H Cooling Gel UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Preparation H 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 Preparation H 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".