55714-2540 NDC - VITILIGO (ECHINACEA, IRIS VERSICOLOR, RUMEX CRISPUS, BERBERIS VULGARIS, BOVISTA, DOLICHOS PRURIENS, HURA BRASILIENSIS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MEZEREUM, RHUS TOXICODENDRON, SEPIA, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, URTICA URENS, ARSENICUM ALBUM)

Drug Information

Product NDC: 55714-2540

Proprietary Name: Vitiligo

Non Proprietary Name: Echinacea, Iris versicolor, Rumex crispus, Berberis vulgaris, Bovista, Dolichos pruriens, Hura brasiliensis, Hydrocotyle asiatica, Lycopodium clavatum, Mezereum, Rhus toxicodendron, Sepia, Taraxacum officinale, Thuja occidentalis, Urtica urens, Arsenicum album

Active Ingredient(s):
  • 15 [hp_X]/mL ARSENIC TRIOXIDE;
  • 10 [hp_X]/mL BERBERIS VULGARIS ROOT BARK;
  • 10 [hp_X]/mL CENTELLA ASIATICA;
  • 10 [hp_X]/mL DAPHNE MEZEREUM BARK;
  • 10 [hp_X]/mL ECHINACEA, UNSPECIFIED;
  • 10 [hp_X]/mL HURA CREPITANS SAP;
  • 6 [hp_X]/mL IRIS VERSICOLOR ROOT;
  • 10 [hp_X]/mL LYCOPERDON UTRIFORME FRUITING BODY;
  • 10 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE;
  • 10 [hp_X]/mL MUCUNA PRURIENS FRUIT TRICHOME;
  • 10 [hp_X]/mL RUMEX CRISPUS ROOT;
  • 10 [hp_X]/mL SEPIA OFFICINALIS JUICE;
  • 10 [hp_X]/mL TARAXACUM OFFICINALE;
  • 10 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG;
  • 10 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF;
  • 10 [hp_X]/mL URTICA URENS


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/1/2019

Package Information

No. Package Code Package Description Billing Unit
155714-2540-250 mL in 1 BOTTLE, GLASS (55714-2540-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-2540The 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 NAMEVitiligoThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEEchinacea, Iris versicolor, Rumex crispus, Berberis vulgaris, Bovista, Dolichos pruriens, Hura brasiliensis, Hydrocotyle asiatica, Lycopodium clavatum, Mezereum, Rhus toxicodendron, Sepia, Taraxacum officinale, Thuja occidentalis, Urtica urens, Arsenicum albumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/2019This 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 NAMENewton Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; IRIS VERSICOLOR ROOT; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; MUCUNA PRURIENS FRUIT TRICHOME; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENSAn 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 STRENGTH15; 10; 10; 10; 10; 10; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 

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