62795-2303 NDC - TRAUMED (ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT)

Drug Information

Product NDC: 62795-2303
Proprietary Name: Traumed
Non Proprietary Name: ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP and COMFREY ROOT
Active Ingredient(s): 2 [hp_X]/1 ACHILLEA MILLEFOLIUM WHOLE; 3 [hp_X]/1 ACONITUM NAPELLUS WHOLE; 3 [hp_X]/1 ARNICA MONTANA WHOLE; 3 [hp_X]/1 ATROPA BELLADONNA; 2 [hp_X]/1 BAPTISIA TINCTORIA ROOT; 2 [hp_X]/1 BELLIS PERENNIS WHOLE; 2 [hp_X]/1 CALENDULA OFFICINALIS FLOWERING TOP; 8 [hp_X]/1 COMFREY ROOT; 2 [hp_X]/1 ECHINACEA ANGUSTIFOLIA WHOLE; 2 [hp_X]/1 HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; 3 [hp_X]/1 HYPERICUM PERFORATUM WHOLE; 2 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE; 4 [hp_X]/1 RUTA GRAVEOLENS FLOWERING TOP
Administration Route(s): ORAL
Dosage Form(s): TABLET, CHEWABLE

Labeler Information

Field Name	Field Value
Labeler Name:	MediNatura Inc
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	3/21/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	62795-2303-2	60 TABLET, CHEWABLE in 1 BOTTLE (62795-2303-2)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	62795-2303	The 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 NAME	HUMAN OTC DRUG	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.
PROPRIETARY NAME	Traumed	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP and COMFREY ROOT	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, CHEWABLE	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/21/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	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.
LABELER NAME	MediNatura Inc	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACHILLEA MILLEFOLIUM WHOLE; ACONITUM NAPELLUS WHOLE; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; MATRICARIA CHAMOMILLA WHOLE; RUTA GRAVEOLENS FLOWERING TOP	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.
ACTIVE NUMERATOR STRENGTH	2; 3; 3; 3; 2; 2; 2; 8; 2; 2; 3; 2; 4
ACTIVE INGRED UNIT	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Drug Information

Labeler Information

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