76348-430 NDC - MAGSOOTHIUM WARMING FORMULA (ARNICA MONTANA, HAMAMELIS VIRGINIANA, MAGNESIA SULPHURICA)

Drug Information

Product NDC: 76348-430

Proprietary Name: MAGSOOTHIUM Warming Formula

Non Proprietary Name: Arnica Montana, Hamamelis Virginiana, Magnesia Sulphurica

Active Ingredient(s):
  • 1.12 g/112g ARNICA MONTANA;
  • 1.12 g/112g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK;
  • .224 g/112g MAGNESIUM SULFATE HEPTAHYDRATE


Administration Route(s): TOPICAL

Dosage Form(s): CREAM

Pharmacy Class(es):
  • Calculi Dissolution Agent [EPC];
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE];
  • Magnesium Ion Exchange Activity [MoA];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Labeler Name: RENU LABORATORIES, INC.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:6/3/2019

Package Information

No. Package Code Package Description Billing Unit
176348-430-01112 g in 1 JAR (76348-430-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC76348-430The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEMAGSOOTHIUM Warming FormulaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEArnica Montana, Hamamelis Virginiana, Magnesia SulphuricaThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/3/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMERENU LABORATORIES, INC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MAGNESIUM SULFATE HEPTAHYDRATEAn 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.
ACTIVE NUMERATOR STRENGTH1.12; 1.12; .224 
ACTIVE INGRED UNITg/112g; g/112g; g/112g 
PHARM CLASSESCalculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

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This page was last updated on: 2/1/2023