Natural Epsom Salt
NDC 69232-001
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Natural Epsom Salt is a OTC MONOGRAPH NOT FINAL-approved product labeled by Anhui Twowin Machinery Imp. & Exp. Co., Ltd.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 69232-001 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
69232-001
Proprietary Name:
Natural Epsom Salt
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
69232
Product Label ID:
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.
Marketing Timeline
Start Marketing Date: [9]
10-09-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 69232-001?
The NDC code 69232-001 is assigned by the FDA to the product Natural Epsom Salt. This pharmaceutical product is labeled by Anhui Twowin Machinery Imp. & Exp. Co., Ltd. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 69232-001-01, 69232-001-02. 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?
Natural Epsom SaltMagnesium Sulfate U.S.P.Soaking SolutionSaline LaxativeSoothes Minor Aches, Sprains & Sore MusclesCalming & RejuvenatingSORE FEET RELIEF: Add one cup of Amoray Care® Epsom Salt to one gallon of warm water and soak for at least 5 minutes at a time.BATH SOAK: Add two cups of Amoray Care® Epsom Salt under warm running bath water to release its gentle aroma. Amoray Care® Epsom Salt helps relieve tension and provides a soothing, relaxing experience. Soak for at least 20 minutes.First Aid Compress: Dissolve 2 cups of Amoray Care® Epsom Salt into two cups of hot water to make a compress, apply as a wet dressing with a towel to: soothe bruises & sprains, take the sting out of insect bites, draw out splinters, alleviate pain from sports and overexertion.Kkeep out of reach of children. Where prompt relief is not obtained or where there is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALTS CAN BE APPLIED FOR EXTERNAL USE ONLY.Store in a cool, dry place out of direct sunlight. Package sold by weight not volume, some settling may occur during shipment. If caking occurs, tap pouch gently to free granules.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- MAGNESIUM SULFATE (UNII: DE08037SAB)
- MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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:
- RxCUI: 1053346 - Epsom salt 100 % Granules for Oral Solution
- RxCUI: 1053346 - magnesium sulfate 1000 MG Granules for Oral Solution
- RxCUI: 1053346 - magnesium sulfate 100 % Granules for Oral Solution
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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".