NDC 23359-032 Ninjacof

Chlophedianol Hcl And Pyrilamine Maleate Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
23359-032
Proprietary Name:
Ninjacof
Non-Proprietary Name: [1]
Chlophedianol Hcl And Pyrilamine Maleate
Substance Name: [2]
Chlophedianol Hydrochloride; Pyrilamine Maleate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Centurion Labs, Llc
    Labeler Code:
    23359
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    10-15-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    COTTON CANDY (C73382)

    Product Packages

    NDC Code 23359-032-04

    Package Description: 120 mL in 1 BOTTLE

    NDC Code 23359-032-10

    Package Description: 10 mL in 1 BOTTLE

    NDC Code 23359-032-16

    Package Description: 473 mL in 1 BOTTLE

    Price per Unit: $0.08400 per ML

    Product Details

    What is NDC 23359-032?

    The NDC code 23359-032 is assigned by the FDA to the product Ninjacof which is a human over the counter drug product labeled by Centurion Labs, Llc. The generic name of Ninjacof is chlophedianol hcl and pyrilamine maleate. The product's dosage form is solution and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 23359-032-04 120 ml in 1 bottle , 23359-032-10 10 ml in 1 bottle , 23359-032-16 473 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 Ninjacof?

    Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritationcalms the cough control center and relieves coughingrunny nosesneezingitching of the nose and throatitchy, watery eyes

    What are Ninjacof 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 Ninjacof UNII Codes?

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

    Which are Ninjacof 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 Ninjacof?

    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: 1593749 - chlophedianol HCl 12.5 MG / pyrilamine maleate 12.5 MG in 5 mL Oral Solution
    • RxCUI: 1593749 - chlophedianol hydrochloride 2.5 MG/ML / pyrilamine maleate 2.5 MG/ML Oral Solution
    • RxCUI: 1593749 - chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 12.5 MG per 5 ML Oral Solution
    • RxCUI: 1593756 - Ninjacof 12.5 MG / 12.5 MG in 5 mL Oral Solution
    • RxCUI: 1593756 - chlophedianol hydrochloride 2.5 MG/ML / pyrilamine maleate 2.5 MG/ML Oral Solution [Ninjacof]

    * 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".