50114-7004 NDC - TRAUMEEL (ARNICA MONTANA ROOT, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA AND HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK)

Drug Information

Product NDC: 50114-7004

Proprietary Name: Traumeel

Non Proprietary Name: ARNICA MONTANA ROOT, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK

Active Ingredient(s):
  • 3 [hp_X]/2.2mL ACHILLEA MILLEFOLIUM;
  • 2 [hp_X]/2.2mL ACONITUM NAPELLUS;
  • 2 [hp_X]/2.2mL ARNICA MONTANA ROOT;
  • 2 [hp_X]/2.2mL ATROPA BELLADONNA;
  • 2 [hp_X]/2.2mL BELLIS PERENNIS;
  • 6 [hp_X]/2.2mL CALCIUM SULFIDE;
  • 2 [hp_X]/2.2mL CALENDULA OFFICINALIS FLOWERING TOP;
  • 6 [hp_X]/2.2mL COMFREY ROOT;
  • 2 [hp_X]/2.2mL ECHINACEA PURPUREA;
  • 2 [hp_X]/2.2mL ECHINACEA, UNSPECIFIED;
  • 1 [hp_X]/2.2mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK;
  • 2 [hp_X]/2.2mL HYPERICUM PERFORATUM;
  • 3 [hp_X]/2.2mL MATRICARIA RECUTITA;
  • 6 [hp_X]/2.2mL MERCURIUS SOLUBILIS


Administration Route(s): INTRA-ARTICULAR; INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS

Dosage Form(s): INJECTION

Labeler Information

Labeler Name: Medinatura
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/9/2007
End Marketing Date:12/31/2024

Package Information

No. Package Code Package Description Billing Unit
150114-7004-110 AMPULE in 1 CARTON (50114-7004-1) / 2.2 mL in 1 AMPULEML
250114-7004-23 AMPULE in 1 CARTON (50114-7004-2) / 2.2 mL in 1 AMPULE

NDC Record

Field Name Field Value Definition
PRODUCT NDC50114-7004The 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 PRESCRIPTION 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 NAMETraumeelThe 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 ROOT, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRA-ARTICULAR; INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/9/2007This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE12/31/2024This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NAMEMedinaturaName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILISAn 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 STRENGTH3; 2; 2; 2; 2; 6; 2; 6; 2; 2; 1; 2; 3; 6 
ACTIVE INGRED UNIT[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 

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