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  4. NDC Product Code: 52183-227 Ludens Dual Relief

NDC 52183-227 Ludens Dual Relief

Pectin And Menthol Lozenge Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52183-227?
  5. Ludens Dual Relief Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
52183-227
Proprietary Name:
Ludens Dual Relief
Non-Proprietary Name: [1]
Pectin And Menthol
Substance Name: [2]
Menthol; Pectin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Prestige Brands Holdings, Inc.
    Labeler Code:
    52183
    Product Label ID:
    d0213cb3-ec8e-40cc-82c9-694032f0490f
    FDA Application Number: [6]
    part356
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    06-15-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Shape:
    OVAL (C48345)
    Size(s):
    22 MM
    Score:
    1
    Flavor(s):
    CHERRY (C73375 - WILD CHERRY)

    Product Packages

    NDC Code 52183-227-25

    Package Description: 25 LOZENGE in 1 BAG

    Product Details

    What is NDC 52183-227?

    The NDC code 52183-227 is assigned by the FDA to the product Ludens Dual Relief which is a human over the counter drug product labeled by Prestige Brands Holdings, Inc.. The generic name of Ludens Dual Relief is pectin and menthol. The product's dosage form is lozenge and is administered via oral form. The product is distributed in a single package with assigned NDC code 52183-227-25 25 lozenge in 1 bag . 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 Ludens Dual Relief?

    Adults and children 3 years of age and older: allow two drops to dissolve slowly in mouthmay be repeated as needed or as directed by a doctorchildren under 3 years of age: ask a doctor

    What are Ludens Dual Relief 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.
    • MENTHOL 2.5 mg/1 - A monoterpene cyclohexanol produced from mint oils.
    • PECTIN 2.8 mg/1 - High molecular weight polysaccharides present in the cell walls of all plants. Pectins cement cell walls together. They are used as emulsifiers and stabilizers in the food industry. They have been tried for a variety of therapeutic uses including as antidiarrheals, where they are now generally considered ineffective, and in the treatment of hypercholesterolemia.

    Which are Ludens Dual Relief UNII Codes?

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

    Which are Ludens Dual Relief 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 Ludens Dual Relief?

    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: 2056063 - menthol 2.5 MG / pectin 2.8 MG Oral Lozenge
    • RxCUI: 2056069 - Luden's Dual Relief 2.5 MG / 2.8 MG Oral Lozenge
    • RxCUI: 2056069 - menthol 2.5 MG / pectin 2.8 MG Oral Lozenge [Luden's Dual Relief]
    • RxCUI: 2056069 - Luden's Dual Relief (menthol 2.5 MG / pectin 2.8) MG Oral Lozenge

    * 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".