50181-0078 NDC - BIOTOX BAC (MYCOPLASMA PNEUMONIAE, PROTEUS (VULGARIS), CANDIDA ALBICANS, COLIBACILLINUM CUM NATRUM MURIATICUM, MYCOBACTERIUM PARATUBERCULOSIS, PASTEURELLOSIS (PASTEURELLA MULTOCIDA), PNEUMOCOCCINUM, THUJA OCCIDENTALIS, MYCOBACTERIUM AVIUM PARATUBERCULOSIS, PHYTOLACCA DECANDRA, LEGIONELLA PNEUMOPHILA, SHIGELLA SONNEI)

Drug Information

Product NDC: 50181-0078
Proprietary Name: BioTox Bac
Non Proprietary Name: Mycoplasma Pneumoniae, Proteus (Vulgaris), Candida Albicans, Colibacillinum Cum Natrum Muriaticum, Mycobacterium Paratuberculosis, Pasteurellosis (Pasteurella Multocida), Pneumococcinum, Thuja Occidentalis, Mycobacterium Avium Paratuberculosis, Phytolacca Decandra, Legionella Pneumophila, Shigella Sonnei
Active Ingredient(s): 15 [hp_X]/mL CANDIDA ALBICANS; 15 [hp_X]/mL ESCHERICHIA COLI; 15 [hp_C]/mL LEGIONELLA PNEUMOPHILA; 15 [hp_X]/mL MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; 9 [hp_X]/mL MYCOPLASMA PNEUMONIAE; 15 [hp_X]/mL PASTEURELLA MULTOCIDA; 6 [hp_C]/mL PHYTOLACCA AMERICANA ROOT; 12 [hp_X]/mL PROTEUS INCONSTANS; 15 [hp_C]/mL SHIGELLA SONNEI; 15 [hp_X]/mL STREPTOCOCCUS PNEUMONIAE; 15 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Fungal Proteins [CS]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Fungal Allergenic Extract [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	The Wellness Center for Research and Education, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	11/8/2021
End Marketing Date:	12/9/2026

Package Information

No.	Package Code	Package Description	Billing Unit
1	50181-0078-1	30 mL in 1 BOTTLE, DROPPER (50181-0078-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	50181-0078	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	BioTox Bac	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX	3	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAME	Mycoplasma Pneumoniae, Proteus (Vulgaris), Candida Albicans, Colibacillinum Cum Natrum Muriaticum, Mycobacterium Paratuberculosis, Pasteurellosis (Pasteurella Multocida), Pneumococcinum, Thuja Occidentalis, Mycobacterium Avium Paratuberculosis, Phytolacca Decandra, Legionella Pneumophila, Shigella Sonnei	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	LIQUID	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	11/8/2021	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	12/9/2026	This 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 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	The Wellness Center for Research and Education, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	CANDIDA ALBICANS; ESCHERICHIA COLI; LEGIONELLA PNEUMOPHILA; MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; MYCOPLASMA PNEUMONIAE; PASTEURELLA MULTOCIDA; PHYTOLACCA AMERICANA ROOT; PROTEUS INCONSTANS; SHIGELLA SONNEI; STREPTOCOCCUS PNEUMONIAE; THUJA OCCIDENTALIS LEAFY TWIG	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	15; 15; 15; 15; 9; 15; 6; 12; 15; 15; 15
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]

Drug Information

Labeler Information

Package Information

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