NDC 44911-0546

Bio-Immune

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),

Bio-Immune is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Energique, Inc.. The primary component is 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 ID: 44911-0546_a44fdb6c-4ce6-48c8-b1ed-4949a896b932
• NDC: 44911-0546
• Product Type: Human Otc Drug
• Proprietary Name: Bio-Immune
• Generic Name: 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),
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-01
• Marketing End Date: 2025-04-22
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Energique, Inc.
• Substance Name: 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
• Active Ingredient Strength: 10 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
• Pharm Classes: Actively Acquired Immunity [PE], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Live Vaccinia Virus Vaccine [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Smallpox Vaccine [CS], Vaccines, Live, Unattenuated [CS]
• NDC Exclude Flag: N

Packaging

NDC 44911-0546-1

30 mL in 1 BOTTLE, DROPPER (44911-0546-1)

• Marketing Start Date: 2020-04-01
• Marketing End Date: 2025-04-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44911-0546-1 [44911054601]

Bio-Immune LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-01

Drug Details

Active Ingredients

Ingredient	Strength
CHELIDONIUM MAJUS WHOLE	3 [hp_X]/mL

OpenFDA Data

• SPL SET ID: 17b5ee2c-20e6-47d1-96f3-aedc5328d2ba
• Manufacturer:
  • Energique, Inc.
• UNII:
  • 5EF0HWI5WU
  • 9PP1T3TC5U
  • XW4JB03TI5
  • M7T6H7D4IF
  • JDS6958QAG
  • 4K7Z7K7SWG
  • 0296055VE0
  • U946SH95EE
  • 7IFM8431X3
  • 1TH8Q20J0U
  • Y3V16D4PV4
  • 3NZW5ND3D6
  • 70FD1KFU70
  • DIF093I037
  • 9N1RM2S62C
  • GHJ5XX5SGS
  • 8V4458342X
  • U364V64HUN
  • D1YM0P5Z2T
  • 01G9XEA93N
  • 7H443NUB2T
  • 4SV59689SK
  • S7V92P67HO
  • 7E889U5RNN
  • RN2HC612GY
  • YHA2XLJ956
  • 1EP6R5562J
  • 39981FM375
  • BT6U234YR2
  • 41LZ22DD4N
  • K2A74U428F
  • 29SUH5R3HU
  • CT03BSA18U
  • 4D7G21HDBC
  • 1PIP394IID
• UPC Code:
  • 0363113700602

NDC Crossover Matching brand name "Bio-Immune" or generic name "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),"

NDC	Brand Name	Generic Name
44911-0376	Bio-Immune	Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Scrophularia Nodosa, Senega Officinalis, Spongia Tosta, Taraxacum Officinale, Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis, Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus, Agaricus Muscarius, Bovista Secale Cornutum, Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus (Bach)
44911-0481	Bio-Immune	Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Scrophularia Nodosa, Senega Officinalis, Spongia Tosta, Taraxacum Officinale, Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis, Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus, Agaricus Muscarius, Bovista, Secale Cornutum, Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus (Bach),
44911-0546	Bio-Immune	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),
44911-0653	Bio-Immune	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),