NDC 54973-3154 Cough Baby

Ipecac,Bryonia Alba Root,Spongia Officinalis Skeleton,Roasted,Phosphorus,Causticum,Drosera - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

Get all the details for National Drug Code (NDC) 54973-3154 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:
54973-3154
Proprietary Name:
Cough Baby
Non-Proprietary Name: [1]
Ipecac, Bryonia Alba Root, Spongia Officinalis Skeleton, Roasted, Phosphorus, Causticum, Drosera Rotundifolia, And Rumex Crispus Root
Substance Name: [2]
Bryonia Alba Root; Causticum; Drosera Rotundifolia; Ipecac; Phosphorus; Rumex Crispus Root; Spongia Officinalis Skeleton, Roasted
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Labeler Code:
54973
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date: [9]
10-17-2012
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

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Product Details

What is NDC 54973-3154?

The NDC code 54973-3154 is assigned by the FDA to the product Cough Baby which is a human over the counter drug product labeled by Hyland's Inc.. The generic name of Cough Baby is ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root. The product's dosage form is syrup and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 54973-3154-1 19.81 ml in 1 bottle, plastic , 54973-3154-2 118 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 Cough Baby?

Measure only with the dosing syringe providedDo not use dosing syringe with other productsOn dosing syringe, mL = milliliter, tsp = teaspoonchildren under 6 months of ageconsult a licensed health care professional before using this productchildren 6 months to under 1 year of age2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)children 1 to 3 years of age5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

What are Cough Baby 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 Cough Baby UNII Codes?

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

Which are Cough Baby 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

[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.

[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".