NDC 44911-0546 Bio-immune
Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Senega Officinalis,...

Product Information
Product Packages
What is NDC 44911-0546?
Bio-immune Uses
Active Ingredients
Active Ingredients UNII Codes
Inactive Ingredients UNII Codes
Pharmacologic Classes

Product Information

NDC Product Code	44911-0546
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Bio-immune
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Senega Officinalis, Spongia Tosta, Taraxacum Officinale, Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis, Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus, Scrophularia Nodosa, Agaricus Muscarius, Bovista, Secale Cornutum, Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus (bach),
Substance Name What is the Substance Name? 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.	Amanita Muscaria Fruiting Body; Arsenic Trioxide; Bacillus Anthracis Immunoserum Rabbit; Baptisia Tinctoria Root; Berberis Vulgaris Root Bark; Cairina Moschata Heart/liver Autolysate; Candida Albicans; Chelidonium Majus Whole; Claviceps Purpurea Sclerotium; Clostridium Botulinum; Crotalus Horridus Horridus Venom; Human Sputum, Bordetella Pertussis Infected; Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (formaldehyde Inactivated); Influenza B Virus B/maryland/15/2016 Antigen (formaldehyde Inactivated); Laricifomes Officinalis Fruiting Body; Lobaria Pulmonaria; Lobelia Inflata Whole; Lycoperdon Utriforme Fruiting Body; Milk Thistle; Polygala Senega Root; Rancid Beef; Rumex Crispus Root; Salmonella Enterica Subsp. Enterica Serovar Enteritidis; Sambucus Nigra Flowering Top; Scrophularia Nodosa Whole; Shigella Dysenteriae; Spongia Officinalis Skeleton, Roasted; Streptococcus Pneumoniae; Sulfur; Taraxacum Officinale; Ustilago Maydis; Vaccinia Virus; Vaccinia Virus Strain New York City Board Of Health Live Antigen; Virola Sebifera Resin
Product Type What kind of product is this? 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.	Human Otc Drug
NDC Directory Status	ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form	Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)? The translation of the route code submitted by the firm, indicating route of administration.	Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Energique, Inc.
Labeler Code	44911
SPL SET ID:	17b5ee2c-20e6-47d1-96f3-aedc5328d2ba
Marketing Category What is the Marketing Category? 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.	UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	04-01-2020
End Marketing Date What is the End Marketing Date? 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.	04-22-2025
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	44911 - Energique, Inc. 44911-0546 - Bio-immune 44911-0546-1

Product Packages

NDC Code 44911-0546-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

Product Details

What is NDC 44911-0546?

The NDC code 44911-0546 is assigned by the FDA to the product Bio-immune which is a human over the counter drug product labeled by Energique, Inc.. The generic name of Bio-immune is chelidonium majus, lobelia inflata, rumex crispus, sambucus nigra, senega officinalis, spongia tosta, taraxacum officinale, myristica sebifera, sticta pulmonaria, sulphur, ustilago maidis, polyporus officinalis, candida albicans, carduus marianus, crotalus horridus, scrophularia nodosa, agaricus muscarius, bovista, secale cornutum, anas barbariae, hepatis et cordis extractum, anthracinum, arsenicum album, baptisia tinctoria, berberis vulgaris, botulinum, dysentery bacillus, gaertner bacillus (bach), . The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 44911-0546-1 30 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Bio-immune?

May temporarily relieve symptoms associated with bacterial and viral conditions, such as fever and chills, and cough.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. May temporarily relieve symptoms associated with bacterial and viral conditions, such as fever and chills, and cough.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

What are Bio-immune Active Ingredients?

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.

AMANITA MUSCARIA FRUITING BODY 10 [hp_C]/mL
ARSENIC TRIOXIDE 30 [hp_C]/mL - An inorganic compound with the chemical formula As2O3 that is used for the treatment of ACUTE PROMYELOCYTIC LEUKEMIA in patients who have relapsed from, or are resistant to, conventional drug therapy.
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL
BAPTISIA TINCTORIA ROOT 30 [hp_C]/mL
BERBERIS VULGARIS ROOT BARK 30 [hp_C]/mL
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30 [hp_C]/mL
CANDIDA ALBICANS 12 [hp_X]/mL - A unicellular budding fungus which is the principal pathogenic species causing CANDIDIASIS (moniliasis).
CHELIDONIUM MAJUS WHOLE 3 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM 10 [hp_C]/mL
CLOSTRIDIUM BOTULINUM 30 [hp_C]/mL - A species of anaerobic, gram-positive, rod-shaped bacteria in the family Clostridiaceae that produces proteins with characteristic neurotoxicity. It is the etiologic agent of BOTULISM in humans, wild fowl, HORSES; and CATTLE. Seven subtypes (sometimes called antigenic types, or strains) exist, each producing a different botulinum toxin (BOTULINUM TOXINS). The organism and its spores are widely distributed in nature.
CROTALUS HORRIDUS HORRIDUS VENOM 12 [hp_X]/mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 30 [hp_C]/mL
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_C]/mL
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_C]/mL
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_C]/mL
LARICIFOMES OFFICINALIS FRUITING BODY 8 [hp_X]/mL
LOBARIA PULMONARIA 6 [hp_X]/mL
LOBELIA INFLATA WHOLE 3 [hp_X]/mL
LYCOPERDON UTRIFORME FRUITING BODY 10 [hp_C]/mL
MILK THISTLE 12 [hp_X]/mL - The plant Silybum marianum in the family ASTERACEAE containing the bioflavonoid complex SILYMARIN. For centuries this has been used traditionally to treat liver disease. Silybum marianum (L.) Gaertn. = Carduus marianus L.
POLYGALA SENEGA ROOT 3 [hp_X]/mL
RANCID BEEF 30 [hp_C]/mL
RUMEX CRISPUS ROOT 3 [hp_X]/mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 30 [hp_C]/mL
SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]/mL
SCROPHULARIA NODOSA WHOLE 12 [hp_X]/mL
SHIGELLA DYSENTERIAE 30 [hp_C]/mL - A species of gram-negative, facultatively anaerobic, rod-shaped bacteria that is extremely pathogenic and causes severe dysentery. Infection with this organism often leads to ulceration of the intestinal epithelium.
SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE 30 [hp_C]/mL - A gram-positive organism found in the upper respiratory tract, inflammatory exudates, and various body fluids of normal and/or diseased humans and, rarely, domestic animals.
SULFUR 6 [hp_X]/mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.
TARAXACUM OFFICINALE 3 [hp_X]/mL - A plant genus of the family Asteraceae. Members contain chicoric and chlorogenic acids and germacrane- and eudesmane-type SESQUITERPENES.
USTILAGO MAYDIS 6 [hp_X]/mL
VACCINIA VIRUS 30 [hp_C]/mL - The type species of ORTHOPOXVIRUS, related to COWPOX VIRUS, but whose true origin is unknown. It has been used as a live vaccine against SMALLPOX. It is also used as a vector for inserting foreign DNA into animals. Rabbitpox virus is a subspecies of VACCINIA VIRUS.
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 30 [hp_C]/mL
VIROLA SEBIFERA RESIN 6 [hp_X]/mL

Which are Bio-immune UNII Codes?

The UNII codes for the active ingredients in this product are:

CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN)
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (Active Moiety)
LOBELIA INFLATA WHOLE (UNII: 9PP1T3TC5U)
LOBELIA INFLATA WHOLE (UNII: 9PP1T3TC5U) (Active Moiety)
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C)
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (Active Moiety)
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U)
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (Active Moiety)
POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF)
POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (Active Moiety)
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID)
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (Active Moiety)
TARAXACUM OFFICINALE (UNII: 39981FM375)
TARAXACUM OFFICINALE (UNII: 39981FM375) (Active Moiety)
VIROLA SEBIFERA RESIN (UNII: GHJ5XX5SGS)
VIROLA SEBIFERA RESIN (UNII: GHJ5XX5SGS) (Active Moiety)
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T)
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (Active Moiety)
SULFUR (UNII: 70FD1KFU70)
SULFUR (UNII: 70FD1KFU70) (Active Moiety)
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG)
USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (Active Moiety)
LARICIFOMES OFFICINALIS FRUITING BODY (UNII: 7IFM8431X3)
LARICIFOMES OFFICINALIS FRUITING BODY (UNII: 7IFM8431X3) (Active Moiety)
CANDIDA ALBICANS (UNII: 4D7G21HDBC)
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (Active Moiety)
MILK THISTLE (UNII: U946SH95EE)
MILK THISTLE (UNII: U946SH95EE) (Active Moiety)
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956)
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (Active Moiety)
SCROPHULARIA NODOSA WHOLE (UNII: 7H443NUB2T)
SCROPHULARIA NODOSA WHOLE (UNII: 7H443NUB2T) (Active Moiety)
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037)
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (Active Moiety)
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F)
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (Active Moiety)
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N)
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (Active Moiety)
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY)
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (Active Moiety)
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N)
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (Active Moiety)
ARSENIC TRIOXIDE (UNII: S7V92P67HO)
ARSENIC CATION (3+) (UNII: C96613F5AV) (Active Moiety)
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU)
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (Active Moiety)
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (Active Moiety)
CLOSTRIDIUM BOTULINUM (UNII: 0296055VE0)
CLOSTRIDIUM BOTULINUM (UNII: 0296055VE0) (Active Moiety)
SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J)
SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (Active Moiety)
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4)
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (Active Moiety)
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: XW4JB03TI5)
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 92XE6GHC89) (Active Moiety)
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 3NZW5ND3D6)
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K329YCD1N9) (Active Moiety)
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8V4458342X)
INFLUENZA B VIRUS B/MARYLAND/15/2016 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: OES3CXI7E9) (Active Moiety)
VACCINIA VIRUS (UNII: JDS6958QAG)
VACCINIA VIRUS (UNII: JDS6958QAG) (Active Moiety)
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN)
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN) (Active Moiety)
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2)
STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (Active Moiety)
RANCID BEEF (UNII: 29SUH5R3HU)
RANCID BEEF (UNII: 29SUH5R3HU) (Active Moiety)
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK)
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK) (Active Moiety)

Which are Bio-immune Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Which are the Pharmacologic Classes for Bio-immune?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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