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  4. NDC Product Code: 58602-030 Childrens Cetirizine Hydrochloride Hives Relief

NDC 58602-030 Childrens Cetirizine Hydrochloride Hives Relief

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58602-030?
  5. Childrens Cetirizine Hydrochloride Hives Relief Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
58602-030
Proprietary Name:
Childrens Cetirizine Hydrochloride Hives Relief
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:
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]
    Aurohealth Llc
    Labeler Code:
    58602
    Product Label ID:
    e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d
    FDA Application Number: [6]
    ANDA090750
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-24-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - COLORLESS TO PALE YELLOW)
    Flavor(s):
    CHERRY (C73375 - CHERRY MINT)

    Product Packages

    NDC Code 58602-030-20

    Package Description: 1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE

    NDC Code 58602-030-24

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

    NDC Code 58602-030-26

    Package Description: 480 mL in 1 BOTTLE

    Product Details

    What is NDC 58602-030?

    The NDC code 58602-030 is assigned by the FDA to the product Childrens Cetirizine Hydrochloride Hives Relief which is a human over the counter drug product labeled by Aurohealth Llc. The generic name of Childrens Cetirizine Hydrochloride Hives Relief is cetirizine hydrochloride. The product's dosage form is solution and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 58602-030-20 1 bottle in 1 carton / 240 ml in 1 bottle, 58602-030-24 1 bottle in 1 carton / 120 ml in 1 bottle, 58602-030-26 480 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 Cetirizine Hydrochloride Hives Relief?

    Use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over  1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.adults 65 years and over  1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children under 6 years of age  ask a doctorconsumers with liver or kidney disease     ask a doctor

    What are Childrens Cetirizine Hydrochloride Hives Relief 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 Cetirizine Hydrochloride Hives Relief UNII Codes?

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

    Which are Childrens Cetirizine Hydrochloride Hives Relief 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 Cetirizine Hydrochloride Hives Relief?

    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:

    Which are the Pharmacologic Classes for Childrens Cetirizine Hydrochloride Hives Relief?

    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.

    Patient Education

    Cetirizine Injection


    Cetirizine injection is used to treat acute urticaria in adults and children 6 months of age or older. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    * 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".