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  4. NDC Product Code: 41167-3530 Childrens Xyzal Allergy

NDC 41167-3530 Childrens Xyzal Allergy

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 41167-3530?
  5. Childrens Xyzal Allergy Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 41167-3530 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
41167-3530
Proprietary Name:
Childrens Xyzal Allergy
Product Type: [3]
Labeler Name: [5]
Chattem, Inc.
Labeler Code:
41167
Product Label ID:
a33f2704-d350-428b-b467-91f4775ce17f
FDA Application Number: [6]
NDA209090
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
02-01-2023
End Marketing Date: [10]
11-01-2025
Listing Expiration Date: [11]
11-01-2025
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Flavor(s):
TUTTI FRUTTI (C73420)

Code Structure Chart

Product Details

What is NDC 41167-3530?

The NDC code 41167-3530 is assigned by the FDA to the product Childrens Xyzal Allergy which is product labeled by Chattem, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 41167-3530-1 1 bottle in 1 carton / 148 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 Xyzal Allergy?

Use only with enclosed dosing cupadults 65 years of age and older■ ask a doctoradults and children 12-64 years of age■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours children 6-11 years of age■ take 5 mL once daily in the evening■ do not take more than 5 mL in 24 hourschildren 2-5 years of age■ take 2.5 mL once daily in the evening■ do not take more than 2.5 mL in 24 hourschildren under 2 years of age■ do not useconsumers with kidney disease■ do not useNote: mL = milliliters

Which are Childrens Xyzal Allergy UNII Codes?

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

  • LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA)
  • LEVOCETIRIZINE (UNII: 6U5EA9RT2O) (Active Moiety)

Which are Childrens Xyzal Allergy 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:

* Please review the disclaimer below.

Patient Education

Levocetirizine


Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other substances such as dust mites, animal dander, and mold. It is also used to treat symptoms of hives, including itching and rash. Levocetirizine 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

[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.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".