NDC 72476-602 Epsom Salt

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

Product Information

NDC Product Code:
72476-602
Proprietary Name:
Epsom Salt
Non-Proprietary Name: [1]
Magnesium Sulfate
Substance Name: [2]
Magnesium Sulfate Heptahydrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
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]
    Retail Business Services, Llc
    Labeler Code:
    72476
    FDA Application Number: [6]
    part334
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    05-06-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 72476-602-04

    Package Description: 1814 g in 1 POUCH

    NDC Code 72476-602-43

    Package Description: 454 g in 1 POUCH

    Product Details

    What is NDC 72476-602?

    The NDC code 72476-602 is assigned by the FDA to the product Epsom Salt which is a human over the counter drug product labeled by Retail Business Services, Llc. The generic name of Epsom Salt is magnesium sulfate. The product's dosage form is granule, for solution and is administered via oral; topical form. The product is distributed in 2 packages with assigned NDC codes 72476-602-04 1814 g in 1 pouch , 72476-602-43 454 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 recommended daily dosagedrink a full glass (8 ounces) of liquid with each dosemay be taken as a single daily dose or in divided dosesdissolve the dose in 8 ounces of water. Lemon juice may be added to improve the tasteadults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) dailychildren 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) dailychildren under 6 years - consult a doctor

    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 HEPTAHYDRATE (UNII: SK47B8698T)
    • 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.

    [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".