43857-0533 NDC - PNEUMOTOX (TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,)

Drug Information

  • Product NDC: 43857-0533
  • Proprietary Name: Pneumotox
  • Non Proprietary Name: Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea (Angustifolia), Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Iodium, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Trifolium Pratense, Trigonella Foenum-Graecum, Symphytum Officinale, Lung (Suis), Oryza Sativa, Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Benzinum, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album, Natrum Muriaticum, Nitricum Acidum,
  • Active Ingredient(s): 9 [hp_X]/mL ACETONE; 3 [hp_X]/mL ALFALFA; 9 [hp_X]/mL AMMONIUM CHLORIDE; 3 [hp_X]/mL ARNICA MONTANA; 12 [hp_X]/mL ARSENIC TRIOXIDE; 3 [hp_X]/mL ASCLEPIAS TUBEROSA ROOT; 9 [hp_X]/mL BENZENE; 3 [hp_X]/mL DAIKON; 3 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE; 3 [hp_X]/mL EUCALYPTUS GLOBULUS LEAF; 3 [hp_X]/mL FUCUS VESICULOSUS; 3 [hp_X]/mL HORDEUM VULGARE TOP; 3 [hp_X]/mL IODINE; 3 [hp_X]/mL MATRICARIA RECUTITA; 3 [hp_X]/mL NASTURTIUM OFFICINALE; 12 [hp_X]/mL NITRIC ACID; 12 [hp_X]/mL OENANTHE AQUATICA FRUIT; 8 [hp_X]/mL ORYZA SATIVA WHOLE; 12 [hp_X]/mL PHOSPHORIC ACID; 12 [hp_X]/mL PHOSPHORUS; 3 [hp_X]/mL PLANTAGO MAJOR; 9 [hp_X]/mL PROPYLENE GLYCOL; 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE; 8 [hp_X]/mL SILICON DIOXIDE; 12 [hp_X]/mL SODIUM CHLORIDE; 9 [hp_X]/mL SODIUM LAURYL SULFATE; 9 [hp_X]/mL SODIUM TRIPOLYPHOSPHATE; 8 [hp_X]/mL SUS SCROFA LUNG; 6 [hp_X]/mL SYMPHYTUM OFFICINALE WHOLE; 12 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF; 3 [hp_X]/mL TRIFOLIUM PRATENSE FLOWER; 3 [hp_X]/mL TRIGONELLA FOENUM-GRAECUM WHOLE; 1 [hp_X]/mL TRITICUM AESTIVUM WHOLE; 9 [hp_X]/mL TURPENTINE OIL
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID

Labeler Information

Field Name Field Value
Labeler Name: BioActive Nutritional, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:10/2/2019

Package Information

No. Package Code Package Description Billing Unit
143857-0533-130 mL in 1 BOTTLE, DROPPER (43857-0533-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43857-0533The 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 NAMEPneumotoxThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETriticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea (Angustifolia), Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Iodium, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Trifolium Pratense, Trigonella Foenum-Graecum, Symphytum Officinale, Lung (Suis), Oryza Sativa, Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Benzinum, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album, Natrum Muriaticum, Nitricum Acidum,The 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 DATE10/2/2019This 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 NAMEBioActive Nutritional, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETONE; ALFALFA; AMMONIUM CHLORIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; ASCLEPIAS TUBEROSA ROOT; BENZENE; DAIKON; ECHINACEA ANGUSTIFOLIA WHOLE; EUCALYPTUS GLOBULUS LEAF; FUCUS VESICULOSUS; HORDEUM VULGARE TOP; IODINE; MATRICARIA RECUTITA; NASTURTIUM OFFICINALE; NITRIC ACID; OENANTHE AQUATICA FRUIT; ORYZA SATIVA WHOLE; PHOSPHORIC ACID; PHOSPHORUS; PLANTAGO MAJOR; PROPYLENE GLYCOL; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; SUS SCROFA LUNG; SYMPHYTUM OFFICINALE WHOLE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM WHOLE; TURPENTINE OILAn 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; 3; 9; 3; 12; 3; 9; 3; 3; 3; 3; 3; 3; 3; 3; 12; 12; 8; 12; 12; 3; 9; 12; 8; 12; 9; 9; 8; 6; 12; 3; 3; 1; 9 
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; [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; [hp_X]/mL; [hp_X]/mL 

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This page was last updated on: 12/6/2025

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