55758-318 NDC - DESINTOX (ANTIMONIUM CRUDUM,ARGENTUM NITRICUM,CHOLESTERINUM, ROBINIA PSEUDO-ACACIA,CARBO VEGETABILIS,CINCHONA,AESCULUS HIPPOCASTANUM,ARNICA MONTANA,BERBERIS VULGARIS,CEANOTHUS AMERICANUS, CYNARA SCOLYMUS,EQUISETUM ARVENSE,ERIGERON CANADENSIS,FUCUS VESICULOSUS,GINKGO BILOBA,HAMAMELIS VIRGINIANA,HELONIAS DIOICA,HYDRASTIS CANADENSIS,HYDRASTIS CANADENSIS,LAPPA MAJOR,LESPEDEZA CAPITATA,RAPHANUS SATIVUS,TARAXACUM OFFICINALE,VIBURNUM PRUNIFOLIUM,VITIS VINIFERA,RANUNCULUS BULBOSUS)

Drug Information

  • Product NDC: 55758-318
  • Proprietary Name: DESINTOX
  • Non Proprietary Name: Antimonium crudum,Argentum nitricum,Cholesterinum, Robinia pseudo-acacia,Carbo vegetabilis,Cinchona,Aesculus hippocastanum,Arnica montana,Berberis vulgaris,Ceanothus americanus, Cynara scolymus,Equisetum arvense,Erigeron canadensis,Fucus vesiculosus,Ginkgo biloba,Hamamelis virginiana,Helonias dioica,Hydrastis canadensis,Hydrastis canadensis,Lappa major,Lespedeza capitata,Raphanus sativus,Taraxacum officinale,Viburnum prunifolium,Vitis vinifera,Ranunculus bulbosus
  • Active Ingredient(s): 9 [hp_X]/60mL ACTIVATED CHARCOAL; 10 [hp_X]/60mL ANTIMONY TRISULFIDE; 6 [hp_X]/60mL ARCTIUM LAPPA ROOT; 6 [hp_X]/60mL ARNICA MONTANA; 6 [hp_X]/60mL BERBERIS VULGARIS ROOT BARK; 6 [hp_X]/60mL CEANOTHUS AMERICANUS LEAF; 6 [hp_X]/60mL CHAMAELIRIUM LUTEUM ROOT; 8 [hp_X]/60mL CINCHONA BARK; 6 [hp_X]/60mL CYNARA SCOLYMUS LEAF; 6 [hp_X]/60mL EQUISETUM ARVENSE TOP; 6 [hp_X]/60mL ERIGERON CANADENSIS; 6 [hp_X]/60mL FUCUS VESICULOSUS; 10 [hp_X]/60mL GINKGO; 6 [hp_X]/60mL GOLDENSEAL; 6 [hp_X]/60mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; 6 [hp_X]/60mL HORSE CHESTNUT; 6 [hp_X]/60mL LESPEDEZA CAPITATA FLOWERING TOP; 6 [hp_X]/60mL RADISH; 4 [hp_X]/60mL RANUNCULUS BULBOSUS; 10 [hp_X]/60mL ROBINIA PSEUDOACACIA BARK; 10 [hp_X]/60mL SILVER NITRATE; 6 [hp_X]/60mL TARAXACUM OFFICINALE; 6 [hp_X]/60mL VIBURNUM PRUNIFOLIUM BARK; 6 [hp_X]/60mL VITIS VINIFERA WHOLE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Vegetable Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Pharmadel LLC
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
155758-318-021 BOTTLE in 1 BOX (55758-318-02) / 60 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC55758-318The 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 NAMEDESINTOXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAntimonium crudum,Argentum nitricum,Cholesterinum, Robinia pseudo-acacia,Carbo vegetabilis,Cinchona,Aesculus hippocastanum,Arnica montana,Berberis vulgaris,Ceanothus americanus, Cynara scolymus,Equisetum arvense,Erigeron canadensis,Fucus vesiculosus,Ginkgo biloba,Hamamelis virginiana,Helonias dioica,Hydrastis canadensis,Hydrastis canadensis,Lappa major,Lespedeza capitata,Raphanus sativus,Taraxacum officinale,Viburnum prunifolium,Vitis vinifera,Ranunculus bulbosusThe 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 NAMEPharmadel LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CEANOTHUS AMERICANUS LEAF; CHAMAELIRIUM LUTEUM ROOT; CINCHONA BARK; CYNARA SCOLYMUS LEAF; EQUISETUM ARVENSE TOP; ERIGERON CANADENSIS; FUCUS VESICULOSUS; GINKGO; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LESPEDEZA CAPITATA FLOWERING TOP; RADISH; RANUNCULUS BULBOSUS; ROBINIA PSEUDOACACIA BARK; SILVER NITRATE; TARAXACUM OFFICINALE; VIBURNUM PRUNIFOLIUM BARK; VITIS VINIFERA WHOLEAn 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 STRENGTH9; 10; 6; 6; 6; 6; 6; 8; 6; 6; 6; 6; 10; 6; 6; 6; 6; 6; 4; 10; 10; 6; 6; 6 
ACTIVE INGRED UNIT[hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS] 

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This page was last updated on: 4/25/2025

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