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  4. NDC Product Code: 0573-0556 Preparation H Medicated Wipes

NDC 0573-0556 Preparation H Medicated Wipes

Witch Hazel Cloth Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0573-0556?
  4. Preparation H Medicated Wipes Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0573-0556
Proprietary Name:
Preparation H Medicated Wipes
Non-Proprietary Name: [1]
Witch Hazel
Substance Name: [2]
Witch Hazel
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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:
    8d9961f0-1ecf-d7fb-b6b4-856d636d68e1
    FDA Application Number: [6]
    M015
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    02-02-2004
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0573-0556-07

    Package Description: 10 PACKET in 1 CARTON / 1 CLOTH in 1 PACKET

    NDC Code 0573-0556-20

    Package Description: 48 CLOTH in 1 POUCH

    Price per Unit: $0.08800 per EA

    NDC Code 0573-0556-96

    Package Description: 2 POUCH in 1 CARTON / 48 CLOTH in 1 POUCH (0573-0556-20)

    Product Details

    What is NDC 0573-0556?

    The NDC code 0573-0556 is assigned by the FDA to the product Preparation H Medicated Wipes which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Preparation H Medicated Wipes is witch hazel. The product's dosage form is cloth and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 0573-0556-07 10 packet in 1 carton / 1 cloth in 1 packet, 0573-0556-20 48 cloth in 1 pouch , 0573-0556-96 2 pouch in 1 carton / 48 cloth in 1 pouch (0573-0556-20). 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 Medicated Wipes?

    Open the lid on the top of the wipes pouchpeel back wipes seal, remove completely and discardgrab the top wipe at the edge of the center fold and pull out of pouchclose lid after each use to retain moistureadults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the areause up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discardchildren under 12 years of age: consult a doctor

    What are Preparation H Medicated Wipes 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 Medicated Wipes UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Preparation H Medicated Wipes?

    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:

    * 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".