4 Kids Stuffy Nose And Sinus Tablet
NDC 54973-3406
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
4 Kids Stuffy Nose And Sinus (pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate) 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 white tablet for oral administration. This product entry covers the primary NDC 54973-3406 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
54973-3406
Proprietary Name:
4 Kids Stuffy Nose And Sinus
Non-Proprietary Name: [1]
Pulsatilla Pratensis Whole, Oyster Shell Calcium Carbonate, Crude, Goldenseal And Potassium Dichromate
Substance Name: [2]
Goldenseal; Oyster Shell Calcium Carbonate, Crude; Potassium Dichromate; Pulsatilla Pratensis Whole
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet
- A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
54973
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
01-27-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
9 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 54973-3406?
The NDC code 54973-3406 is assigned by the FDA to the product 4 Kids Stuffy Nose And Sinus. It is commonly known by its generic name, pulsatilla pratensis whole, oyster shell calcium carbonate, crude, goldenseal and potassium dichromate. This pharmaceutical product is labeled by Hyland�s Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 54973-3406-1, 54973-3406-2. 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?
Children 2 yearsto under 6 yearsDissolve 1 tablet under tongue every 4 hoursuntil relieved, up to 72 hours.Children 6 yearsto under 12 yearsDissolve 2 tablets under tongue every 4 hoursuntil relieved, up to 72 hours.Adults and children12 years and overDissolve 3 tablets under tongue every 4 hoursuntil relieved, up to 72 hours.
What are Active Ingredients of this product?
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.
- GOLDENSEAL 6 [hp_X]/1
- OYSTER SHELL CALCIUM CARBONATE, CRUDE 3 [hp_X]/1
- POTASSIUM DICHROMATE 6 [hp_X]/1 - Chromic acid (H2Cr2O7), dipotassium salt. A compound having bright orange-red crystals and used in dyeing, staining, tanning leather, as bleach, oxidizer, depolarizer for dry cells, etc. Medically it has been used externally as an astringent, antiseptic, and caustic. When taken internally, it is a corrosive poison.
- PULSATILLA PRATENSIS WHOLE 6 [hp_X]/1
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- POTASSIUM DICHROMATE (UNII: T4423S18FM)
- DICHROMATE ION (UNII: 9LKY4BFN2V) (Active Moiety)
- OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I)
- OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (Active Moiety)
- PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI)
- PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (Active Moiety)
- GOLDENSEAL (UNII: ZW3Z11D0JV)
- GOLDENSEAL (UNII: ZW3Z11D0JV) (Active Moiety)
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:
- ACACIA (UNII: 5C5403N26O)
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
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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 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.
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".
