NDC 63824-722 Cepacol Extra Strength Sore Throat Sugar Free Cherry

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

Product Information

NDC Product Code:
63824-722
Proprietary Name:
Cepacol Extra Strength Sore Throat Sugar Free Cherry
Non-Proprietary Name: [1]
Benzocaine And Menthol
Substance Name: [2]
Benzocaine; Menthol, Unspecified Form
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]
    Rb Health (us) Llc
    Labeler Code:
    63824
    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]
    07-15-2013
    End Marketing Date: [10]
    09-01-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Shape:
    ROUND (C48348)
    Size(s):
    18 MM
    Imprint(s):
    S
    Score:
    1
    Flavor(s):
    CHERRY (C73375)

    Product Details

    What is NDC 63824-722?

    The NDC code 63824-722 is assigned by the FDA to the product Cepacol Extra Strength Sore Throat Sugar Free Cherry which is a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Cepacol Extra Strength Sore Throat Sugar Free Cherry is benzocaine and menthol. The product's dosage form is lozenge and is administered via oral form. 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 Cepacol Extra Strength Sore Throat Sugar Free Cherry?

    Adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.children under 5 years of age: do not use

    What are Cepacol Extra Strength Sore Throat Sugar Free Cherry 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 Cepacol Extra Strength Sore Throat Sugar Free Cherry UNII Codes?

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

    Which are Cepacol Extra Strength Sore Throat Sugar Free Cherry 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 Cepacol Extra Strength Sore Throat Sugar Free Cherry?

    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: 1235477 - Cepacol Sore Throat 15 MG / 3.6 MG Oral Lozenge
    • RxCUI: 1235477 - benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]
    • RxCUI: 1235477 - Cepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral Lozenge
    • RxCUI: 1235477 - Cepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge
    • RxCUI: 824574 - benzocaine 15 MG / menthol 3.6 MG Oral Lozenge

    Which are the Pharmacologic Classes for Cepacol Extra Strength Sore Throat Sugar Free Cherry?

    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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".