58368-010 NDC - ASUTRA WELLHEAL (SALIX ALBA BARK, STELLARIA MEDIA, COMFREY ROOT, HORSE CHESTNUT, DAPHNE MEZEREUM BARK, EQUISETUM ARVENSE TOP, URTICA URENS, ALTHAEA OFFICINALIS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALENDULA OFFICINALIS FLOWERING TOP)

Drug Information

Product NDC: 58368-010

Proprietary Name: Asutra WellHeal

Non Proprietary Name: Salix Alba Bark, Stellaria Media, Comfrey Root, Horse Chestnut, Daphne Mezereum Bark, Equisetum Arvense Top, Urtica Urens, Althaea Officinalis Root, Hamamelis Virginiana Root Bark/Stem Bark, Calendula Officinalis Flowering Top

Active Ingredient(s):
  • 2 [hp_X]/g CALENDULA OFFICINALIS FLOWERING TOP;
  • 2 [hp_X]/g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK;
  • 2 [hp_X]/g SALIX ALBA BARK;
  • 2 [hp_X]/g URTICA URENS;
  • 2 [hp_X]/g EQUISETUM ARVENSE TOP;
  • 2 [hp_X]/g DAPHNE MEZEREUM BARK;
  • 2 [hp_X]/g HORSE CHESTNUT;
  • 2 [hp_X]/g COMFREY ROOT;
  • 2 [hp_X]/g STELLARIA MEDIA;
  • 2 [hp_X]/g ALTHAEA OFFICINALIS ROOT


Administration Route(s): TOPICAL

Dosage Form(s): CREAM

Labeler Information

Labeler Name: BioLyte Laboratories, LLC
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/7/2020

Package Information

No. Package Code Package Description Billing Unit
158368-010-011 BOTTLE, PUMP in 1 CARTON (58368-010-01) > 28 g in 1 BOTTLE, PUMP

NDC Record

Field Name Field Value Definition
PRODUCT NDC58368-010The 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 NAMEAsutra WellHealThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESalix Alba Bark, Stellaria Media, Comfrey Root, Horse Chestnut, Daphne Mezereum Bark, Equisetum Arvense Top, Urtica Urens, Althaea Officinalis Root, Hamamelis Virginiana Root Bark/Stem Bark, Calendula Officinalis Flowering TopThe 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 DATE8/7/2020This 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 NAMEBioLyte Laboratories, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SALIX ALBA BARK; URTICA URENS; EQUISETUM ARVENSE TOP; DAPHNE MEZEREUM BARK; HORSE CHESTNUT; COMFREY ROOT; STELLARIA MEDIA; ALTHAEA OFFICINALIS ROOTThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2; 2; 2; 2; 2; 2; 2; 2; 2; 2 
ACTIVE INGRED UNIT[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 

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This page was last updated on: 3/5/2021