1. Home
  2. Labeler Index
  3. Family Dollar (family Wellness)
  4. NDC Product Code: 55319-304 Childrens Plus Multi Symptom Cold

NDC 55319-304 Childrens Plus Multi Symptom Cold

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hbr,Phenylephrine Hcl Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55319-304?
  5. Childrens Plus Multi Symptom Cold 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:
55319-304
Proprietary Name:
Childrens Plus Multi Symptom Cold
Non-Proprietary Name: [1]
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl
Substance Name: [2]
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine 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]
    Family Dollar (family Wellness)
    Labeler Code:
    55319
    Product Label ID:
    6f24d350-8979-403b-bed1-dd1740dc5562
    FDA Application Number: [6]
    part341
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    11-30-2014
    End Marketing Date: [10]
    11-30-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    GRAPE (C73391)

    Code Structure Chart

    Product Details

    What is NDC 55319-304?

    The NDC code 55319-304 is assigned by the FDA to the product Childrens Plus Multi Symptom Cold which is a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Childrens Plus Multi Symptom Cold is acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl. 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 55319-304-04 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic. 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 Childrens Plus Multi Symptom Cold?

    This product does not contain directions or complete warnings for adult usemL=millilitershake well before usingdo not give more than 5 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing device keep dosing cup with productif needed, repeat dose every 4 hours while symptoms lastfind the right dose on chart below. If possible, use weight to dose; otherwise, use age Weight (lb)Age (yr) Dose (mL)48-956-1110 mL36-47  4-5do not use unless directed by a doctor under 36under 4do not use

    What are Childrens Plus Multi Symptom Cold 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.
    • ACETAMINOPHEN 160 mg/5mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
    • CHLORPHENIRAMINE MALEATE 1 mg/5mL - A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
    • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

    Which are Childrens Plus Multi Symptom Cold UNII Codes?

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

    Which are Childrens Plus Multi Symptom Cold 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 Childrens Plus Multi Symptom Cold?

    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: 1113397 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Suspension
    • RxCUI: 1113397 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
    • RxCUI: 1113397 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Suspension
    • RxCUI: 1113397 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension

    Which are the Pharmacologic Classes for Childrens Plus Multi Symptom Cold?

    * 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".