1. Home
  2. Labeler Index
  3. Family Wellness
  4. NDC Product Code: 55319-104 Childrens All Day Allergy Sugar Free Grape

NDC 55319-104 Childrens All Day Allergy Sugar Free Grape

Cetirizine Hydrochloride Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55319-104?
  5. Childrens All Day Allergy Sugar Free Grape Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
55319-104
Proprietary Name:
Childrens All Day Allergy Sugar Free Grape
Non-Proprietary Name: [1]
Cetirizine Hydrochloride
Substance Name: [2]
Cetirizine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Family Wellness
    Labeler Code:
    55319
    Product Label ID:
    f932da65-6cfa-41d9-b522-ecd7c0217e1d
    FDA Application Number: [6]
    ANDA090182
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    04-22-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - COLORLESS TO SLIGHTLY YELLOW)
    Flavor(s):
    GRAPE (C73391)
    BANANA (C73364)

    Product Packages

    NDC Code 55319-104-07

    Package Description: 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

    NDC Code 55319-104-08

    Package Description: 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

    Product Details

    What is NDC 55319-104?

    The NDC code 55319-104 is assigned by the FDA to the product Childrens All Day Allergy Sugar Free Grape which is a human over the counter drug product labeled by Family Wellness. The generic name of Childrens All Day Allergy Sugar Free Grape is cetirizine hydrochloride. The product's dosage form is suspension and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 55319-104-07 1 bottle in 1 carton / 118 ml in 1 bottle, 55319-104-08 1 bottle in 1 carton / 120 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 Childrens All Day Allergy Sugar Free Grape?

    Use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and older5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

    What are Childrens All Day Allergy Sugar Free Grape 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 Childrens All Day Allergy Sugar Free Grape UNII Codes?

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

    Which are Childrens All Day Allergy Sugar Free Grape 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:

    Which are the Pharmacologic Classes for Childrens All Day Allergy Sugar Free Grape?

    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.

    [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".