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  4. NDC Product Code: 69367-183 Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride

NDC 69367-183 Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride

Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69367-183?
  5. Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
69367-183
Proprietary Name:
Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride
Non-Proprietary Name: [1]
Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride
Substance Name: [2]
Chlophedianol Hydrochloride; Dexchlorpheniramine Maleate; Pseudoephedrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Westminster Pharmaceuticals, Llc
    Labeler Code:
    69367
    Product Label ID:
    7e3b8a3d-f80c-4379-abde-cfac8308580c
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    07-29-2021
    End Marketing Date: [10]
    10-01-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    FRUIT (C73389)

    Product Packages

    NDC Code 69367-183-16

    Package Description: 473 mL in 1 BOTTLE

    Price per Unit: $0.09755 per ML

    Product Details

    What is NDC 69367-183?

    The NDC code 69367-183 is assigned by the FDA to the product Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride which is a human over the counter drug product labeled by Westminster Pharmaceuticals, Llc. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 69367-183-16 473 ml in 1 bottle . 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 Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride?

    Do not exceed recommended dosage.adults and children 12 years of age and over:2 teaspoonfuls every 6 hours, not to exeed 8 teaspoonfuls in 24 hours.children 6 to under 12 years of age:1 teaspoonful every 6 hours, not to exeed 4 teaspoonfuls in 24 hours.children under 6 years of age:consult a doctor

    What are Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride 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 Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride UNII Codes?

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

    Which are Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride 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 Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride?

    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: 1369424 - chlophedianol HCl 12.5 MG / dexchlorpheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution
    • RxCUI: 1369424 - chlophedianol hydrochloride 2.5 MG/ML / dexchlorpheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
    • RxCUI: 1369424 - chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution

    Which are the Pharmacologic Classes for Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride?

    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".