NDC 55319-395 Epsom Salt

Magnesium Sulfate Granule Oral; Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
55319-395
Proprietary Name:
Epsom Salt
Non-Proprietary Name: [1]
Magnesium Sulfate
Substance Name: [2]
Magnesium Sulfate, Unspecified
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Granule - A small particle or grain.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Family Dollar (family Wellness)
    Labeler Code:
    55319
    FDA Application Number: [6]
    M007
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    12-31-2017
    End Marketing Date: [10]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 55319-395-02

    Package Description: 907 g in 1 POUCH

    NDC Code 55319-395-04

    Package Description: 1814 g in 1 POUCH

    Product Details

    What is NDC 55319-395?

    The NDC code 55319-395 is assigned by the FDA to the product Epsom Salt which is a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Epsom Salt is magnesium sulfate. The product's dosage form is granule and is administered via oral; topical form. The product is distributed in 2 packages with assigned NDC codes 55319-395-02 907 g in 1 pouch , 55319-395-04 1814 g in 1 pouch . 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 Epsom Salt?

    Do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hoursagedose adults and children 12  years and older 2-4 level teaspoons dissolved in a full glass (8oz) of water  children 6 to 11 years1-2 level teaspoons in a full glass (8oz) of waterNot recommended for children under 6 years of age.

    What are Epsom Salt 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 Epsom Salt UNII Codes?

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

    • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
    • MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Epsom Salt?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Epsom Salt?

    * 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.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".