NDC 54973-2956 Leg Cramps

Cinchona Officinalis Bark,Aconitum Napellus,Pseudognaphalium Obtusifolium,Ledum Palustre - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

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
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 Name: [5]
    Hyland's Consumer Health Inc.
    Labeler Code:
    54973
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    12-04-1995
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    Score:
    1

    Product Packages

    NDC Code 54973-2956-1

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

    NDC Code 54973-2956-2

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

    NDC Code 54973-2956-4

    Package Description: 4 PACKET in 1 CARTON / 4 TABLET, SOLUBLE in 1 PACKET

    NDC Code 54973-2956-6

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 54973-2956?

    The NDC code 54973-2956 is assigned by the FDA to the product Leg Cramps which is a human over the counter drug product labeled by Hyland's Consumer Health Inc.. The generic name of Leg Cramps is cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top. The product's dosage form is tablet, soluble and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 54973-2956-1 1 bottle, plastic in 1 carton / 50 tablet, soluble in 1 bottle, plastic, 54973-2956-2 1 bottle, plastic in 1 carton / 100 tablet, soluble in 1 bottle, plastic, 54973-2956-4 4 packet in 1 carton / 4 tablet, soluble in 1 packet, 54973-2956-6 1 bottle, plastic in 1 carton / 100 tablet, soluble in 1 bottle, plastic. 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 Leg Cramps?

    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 Leg Cramps 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 Leg Cramps 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 Leg Cramps 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:

    Which are the Pharmacologic Classes for Leg Cramps?

    * Please review the disclaimer below.

    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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".