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  4. NDC Product Code: 61941-0400 Cold-eeze Childrens Daytime Cough And Chest Congestion Relief

NDC 61941-0400 Cold-eeze Childrens Daytime Cough And Chest Congestion Relief

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61941-0400?
  5. Cold-eeze Childrens Daytime Cough And Chest Congestion Relief Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 61941-0400 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:
61941-0400
Proprietary Name:
Cold-eeze Childrens Daytime Cough And Chest Congestion Relief
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Prophase Labs, Inc.
Labeler Code:
61941
Product Label ID:
ad03d349-c07c-41a2-9627-881098b3e85b
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]
01-01-2016
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR/WHITE)
Flavor(s):
CHERRY (C73375)

Code Structure Chart

Product Details

What is NDC 61941-0400?

The NDC code 61941-0400 is assigned by the FDA to the product Cold-eeze Childrens Daytime Cough And Chest Congestion Relief which is product labeled by Prophase Labs, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 61941-0400-1 180 ml in 1 bottle, unit-dose . 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 Cold-eeze Childrens Daytime Cough And Chest Congestion Relief?

Measure with dosing cup provideddose as follows or as directed by a doctormL = milliliter AgeDosechildren 6 years to under 12 years5 mL (1 tsp) - 10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hourschildren 4 years to under 6 years2.5 mL (1/2 tsp) - 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hourschildren under 4 yearsdo not use

Which are Cold-eeze Childrens Daytime Cough And Chest Congestion Relief UNII Codes?

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

Which are Cold-eeze Childrens Daytime Cough And Chest Congestion 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:

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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.

[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".