Leg Cramps Tablet, Soluble
NDC 54973-2956

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54973-2956?
  5. Leg Cramps Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Leg Cramps (cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Hyland's Consumer Health Inc.. This medication is typically used as a calculi dissolution agent [epc]. It is supplied as a white tablet, soluble for oral administration. This product entry covers the primary NDC 54973-2956 and 5 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54973-2956
Proprietary Name:
Leg Cramps
Non-Proprietary Name: [1]
Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top
Substance Name: [2]
Aconitum Napellus; Cinchona Officinalis Bark; Ledum Palustre Twig; Magnesium Phosphate, Dibasic Trihydrate; Pseudognaphalium Obtusifolium; Toxicodendron Pubescens Leaf; Viscum Album Fruiting Top
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Soluble - A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Hyland's Consumer Health Inc.
Labeler Code:
54973
Product Label ID:
53425c3b-6117-475c-bd8c-08f05b452078
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
12-04-1995
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 54973-2956?

The NDC code 54973-2956 is assigned by the FDA to the product Leg Cramps. It is commonly known by its generic name, cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top. This pharmaceutical product is labeled by Hyland's Consumer Health Inc. and is currently categorized as listed product. The medication is a tablet, soluble administered via oral route. In terms of distribution, this product is available in 5 different package configurations. The associated package NDC(s) include: 54973-2956-1, 54973-2956-2, 54973-2956-3, 54973-2956-4, 54973-2956-6. 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?

Adults and children12 years and overDissolve 2–3 tablets under tongue every 4 hours. If the initialdosage is not providing relief, dissolve 2–3 tablets undertongue every 15 minutes, up to 6 doses.Under 12 years of ageConsult a physician.

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.

Which are the associated UNII Codes?

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

  • CINCHONA OFFICINALIS BARK (UNII: S003A158SB)
  • CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (Active Moiety)
  • ACONITUM NAPELLUS (UNII: U0NQ8555JD)
  • ACONITUM NAPELLUS (UNII: U0NQ8555JD) (Active Moiety)
  • PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW)
  • PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (Active Moiety)
  • LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P)
  • LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (Active Moiety)
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q)
  • MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)
  • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A)
  • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (Active Moiety)
  • VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
  • VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (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:

Which are the Pharmacologic Classes of this product?

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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".