4 Kids Cold And Cough Day And Night Grape Flavor Kit
NDC 54973-3379

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54973-3379?
  5. 4 Kids Cold And Cough Day And Night Grape Flavor Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

4 Kids Cold And Cough Day And Night Grape Flavor (onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Hyland's Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit for oral administration. This product entry covers the primary NDC 54973-3379 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54973-3379
Proprietary Name:
4 Kids Cold And Cough Day And Night Grape Flavor
Non-Proprietary Name: [1]
Onion, Anemone Pulsatilla, Phosphorus, Goldenseal, Calcium Sulfide, Sodium Chloride, Sulfur, Matricaria Chamomilla And Arabica Coffee Bean
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Hyland's Inc.
Labeler Code:
54973
Product Label ID:
79f26bb5-15ad-e40a-e053-2991aa0aaab3
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
12-01-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 54973-3379?

The NDC code 54973-3379 is assigned by the FDA to the product 4 Kids Cold And Cough Day And Night Grape Flavor. It is commonly known by its generic name, onion, anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean. This pharmaceutical product is labeled by Hyland's Inc. and is currently categorized as listed product. The medication is a kit administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54973-3379-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

■ Shake well before using.■ Measure only with the dosing cup provided.■ Do not use dosing cup with other products.■ On dosing cup, mL = milliliter. Shake well before using.Measure only with the dosing cup provided.Do not use dosing cup with other products.On dosing cup, mL = milliliter.Children 2 yearsto under 6 years5 mL at bedtime and every4 hours during the nightuntil relievedChildren 6 yearsto under 12 years10 mL at bedtime and every4 hours during the nightuntil relievedAdults and children12 years and over15 mL at bedtime and every4 hours during the nightuntil relieved

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 & Regulatory Definitions
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".