Royal Epsom Salt Granule, For Solution
NDC Package 50438-001-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Royal Epsom Salt (magnesium sulfate) granules is directionsDrink a full glass (8 ounces) of liquid with each dose.The dose may be taken as a single daily dose or in divided doses.1 teaspoon equals 5 grams.Adults and children 12 years and over - Oral dosage is 10 to 30 gramschildren 6 to under 12 years of age - Oral dosage is 5 to 10 gramschildren 2 to under 6 years of age - Oral dosage is 2.5 to 5 gramschildren under 2 years of age - consult a doctor. This formulation utilizes a granule, for solution delivery system. Marketed by Filo America, this product is identified by NDC 50438-001 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
50438-001-00
Package Description
1.8 kg in 1 BAG
Product Code
50438-001
11-Digit Billing Format
50438000100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Royal Epsom Salt
Non-Proprietary Name
Magnesium Sulfate
Substance Name
Magnesium Sulfate, Unspecified Form
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MAGNESIUM SULFATE, UNSPECIFIED FORM 1 kg/kg
Pharmacologic Class
Usage Information
DirectionsDrink a full glass (8 ounces) of liquid with each dose.The dose may be taken as a single daily dose or in divided doses.1 teaspoon equals 5 grams.Adults and children 12 years and over - Oral dosage is 10 to 30 gramschildren 6 to under 12 years of age - Oral dosage is 5 to 10 gramschildren 2 to under 6 years of age - Oral dosage is 2.5 to 5 gramschildren under 2 years of age - consult a doctor

Regulatory & Marketing

Labeler Name
Filo America
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-29-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50438-001-00 identifies a specific commercial package of 1.8 kg in 1 bag of Royal Epsom Salt, a human over the counter drug labeled by Filo America. This granule, for solution is formulated for oral use and contains magnesium sulfate, unspecified form as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Filo America on October 29, 2014. The current certification is valid through December 31, 2027.

How is this Filo America product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50438000100. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50438-001-00
11-Digit CMS (5-4-2)
50438-0001-00

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.