bio-immune

Generic: 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),

Labeler: energique, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand 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),
Labeler energique, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

amanita muscaria fruiting body 10 [hp_C]/mL, arsenic trioxide 30 [hp_C]/mL, 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, chelidonium majus whole 3 [hp_X]/mL, claviceps purpurea sclerotium 10 [hp_C]/mL, clostridium botulinum 30 [hp_C]/mL, crotalus horridus horridus venom 12 [hp_X]/mL, human sputum, bordetella pertussis infected 30 [hp_C]/mL, influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated) 30 [hp_C]/mL, influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) 30 [hp_C]/mL, influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated) 30 [hp_C]/mL, influenza b virus b/washington/02/2019 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, 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, spongia officinalis skeleton, roasted 3 [hp_X]/mL, streptococcus pneumoniae 30 [hp_C]/mL, sulfur 6 [hp_X]/mL, taraxacum officinale 3 [hp_X]/mL, ustilago maydis 6 [hp_X]/mL, vaccinia virus 30 [hp_C]/mL, vaccinia virus strain new york city board of health live antigen 30 [hp_C]/mL, virola sebifera resin 6 [hp_X]/mL

Manufacturer
Energique, Inc.

Identifiers & Regulatory

Product NDC 44911-0653
Product ID 44911-0653_5022d2ed-631e-4d4c-89b9-5d80e48e8c5b
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Marketing Start 2022-03-21
Marketing End 2027-04-27

Pharmacologic Class

Established (EPC)
non-standardized fungal allergenic extract [epc] live vaccinia virus vaccine [epc]
Chemical Structure
fungal proteins [cs] allergens [cs] smallpox vaccine [cs] vaccines, live, unattenuated [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe] actively acquired immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 449110653
Hyphenated Format 44911-0653

Supplemental Identifiers

UNII
DIF093I037 S7V92P67HO 41LZ22DD4N 5EF0HWI5WU 1TH8Q20J0U RN2HC612GY 4D7G21HDBC 7E889U5RNN 01G9XEA93N 0296055VE0 YHA2XLJ956 U364V64HUN V529EJB2CX WD5E5VYM2E B93BQX9789 VEH9U90EHX 7IFM8431X3 D1YM0P5Z2T 9PP1T3TC5U K2A74U428F U946SH95EE M7T6H7D4IF 29SUH5R3HU 9N1RM2S62C Y3V16D4PV4 CT03BSA18U 7H443NUB2T 1EP6R5562J 1PIP394IID BT6U234YR2 70FD1KFU70 39981FM375 4K7Z7K7SWG JDS6958QAG 4SV59689SK GHJ5XX5SGS
NUI
N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 N0000183917 N0000183364 M0019978 M0569003

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bio-immune (source: ndc)
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), (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 [hp_C]/mL
  • 30 [hp_C]/mL
  • 12 [hp_X]/mL
  • 3 [hp_X]/mL
  • 8 [hp_X]/mL
  • 6 [hp_X]/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (44911-0653-1)
source: ndc

Packages (1)

Ingredients (36)

amanita muscaria fruiting body (10 [hp_C]/mL) arsenic trioxide (30 [hp_C]/mL) 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) chelidonium majus whole (3 [hp_X]/mL) claviceps purpurea sclerotium (10 [hp_C]/mL) clostridium botulinum (30 [hp_C]/mL) crotalus horridus horridus venom (12 [hp_X]/mL) human sputum, bordetella pertussis infected (30 [hp_C]/mL) influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated) (30 [hp_C]/mL) influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) (30 [hp_C]/mL) influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated) (30 [hp_C]/mL) influenza b virus b/washington/02/2019 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) 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) spongia officinalis skeleton, roasted (3 [hp_X]/mL) streptococcus pneumoniae (30 [hp_C]/mL) sulfur (6 [hp_X]/mL) taraxacum officinale (3 [hp_X]/mL) ustilago maydis (6 [hp_X]/mL) vaccinia virus (30 [hp_C]/mL) vaccinia virus strain new york city board of health live antigen (30 [hp_C]/mL) virola sebifera resin (6 [hp_X]/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5022d2ed-631e-4d4c-89b9-5d80e48e8c5b", "openfda": {"nui": ["N0000185372", "N0000175629", "N0000184306", "N0000185001", "M0008890", "M0000728", "N0000183917", "N0000183364", "M0019978", "M0569003"], "unii": ["DIF093I037", "S7V92P67HO", "41LZ22DD4N", "5EF0HWI5WU", "1TH8Q20J0U", "RN2HC612GY", "4D7G21HDBC", "7E889U5RNN", "01G9XEA93N", "0296055VE0", "YHA2XLJ956", "U364V64HUN", "V529EJB2CX", "WD5E5VYM2E", "B93BQX9789", "VEH9U90EHX", "7IFM8431X3", "D1YM0P5Z2T", "9PP1T3TC5U", "K2A74U428F", "U946SH95EE", "M7T6H7D4IF", "29SUH5R3HU", "9N1RM2S62C", "Y3V16D4PV4", "CT03BSA18U", "7H443NUB2T", "1EP6R5562J", "1PIP394IID", "BT6U234YR2", "70FD1KFU70", "39981FM375", "4K7Z7K7SWG", "JDS6958QAG", "4SV59689SK", "GHJ5XX5SGS"], "spl_set_id": ["5f3e6e90-3495-4dee-93d2-1a272b075125"], "pharm_class_cs": ["Fungal Proteins [CS]", "Allergens [CS]", "Smallpox Vaccine [CS]", "Vaccines, Live, Unattenuated [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]", "Actively Acquired Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Fungal Allergenic Extract [EPC]", "Live Vaccinia Virus Vaccine [EPC]"], "manufacturer_name": ["Energique, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (44911-0653-1)", "package_ndc": "44911-0653-1", "marketing_end_date": "20270427", "marketing_start_date": "20220321"}], "brand_name": "Bio-Immune", "product_id": "44911-0653_5022d2ed-631e-4d4c-89b9-5d80e48e8c5b", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "44911-0653", "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),", "labeler_name": "Energique, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bio-Immune", "active_ingredients": [{"name": "AMANITA MUSCARIA FRUITING BODY", "strength": "10 [hp_C]/mL"}, {"name": "ARSENIC TRIOXIDE", "strength": "30 [hp_C]/mL"}, {"name": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT", "strength": "30 [hp_C]/mL"}, {"name": "BAPTISIA TINCTORIA ROOT", "strength": "30 [hp_C]/mL"}, {"name": "BERBERIS VULGARIS ROOT BARK", "strength": "30 [hp_C]/mL"}, {"name": "CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE", "strength": "30 [hp_C]/mL"}, {"name": "CANDIDA ALBICANS", "strength": "12 [hp_X]/mL"}, {"name": "CHELIDONIUM MAJUS WHOLE", "strength": "3 [hp_X]/mL"}, {"name": "CLAVICEPS PURPUREA SCLEROTIUM", "strength": "10 [hp_C]/mL"}, {"name": "CLOSTRIDIUM BOTULINUM", "strength": "30 [hp_C]/mL"}, {"name": "CROTALUS HORRIDUS HORRIDUS VENOM", "strength": "12 [hp_X]/mL"}, {"name": "HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED", "strength": "30 [hp_C]/mL"}, {"name": "INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)", "strength": "30 [hp_C]/mL"}, {"name": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)", "strength": "30 [hp_C]/mL"}, {"name": "INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)", "strength": "30 [hp_C]/mL"}, {"name": "INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)", "strength": "30 [hp_C]/mL"}, {"name": "LARICIFOMES OFFICINALIS FRUITING BODY", "strength": "8 [hp_X]/mL"}, {"name": "LOBARIA PULMONARIA", "strength": "6 [hp_X]/mL"}, {"name": "LOBELIA INFLATA WHOLE", "strength": "3 [hp_X]/mL"}, {"name": "LYCOPERDON UTRIFORME FRUITING BODY", "strength": "10 [hp_C]/mL"}, {"name": "MILK THISTLE", "strength": "12 [hp_X]/mL"}, {"name": "POLYGALA SENEGA ROOT", "strength": "3 [hp_X]/mL"}, {"name": "RANCID BEEF", "strength": "30 [hp_C]/mL"}, {"name": "RUMEX CRISPUS ROOT", "strength": "3 [hp_X]/mL"}, {"name": "SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS", "strength": "30 [hp_C]/mL"}, {"name": "SAMBUCUS NIGRA FLOWERING TOP", "strength": "3 [hp_X]/mL"}, {"name": "SCROPHULARIA NODOSA WHOLE", "strength": "12 [hp_X]/mL"}, {"name": "SHIGELLA DYSENTERIAE", "strength": "30 [hp_C]/mL"}, {"name": "SPONGIA OFFICINALIS SKELETON, ROASTED", "strength": "3 [hp_X]/mL"}, {"name": "STREPTOCOCCUS PNEUMONIAE", "strength": "30 [hp_C]/mL"}, {"name": "SULFUR", "strength": "6 [hp_X]/mL"}, {"name": "TARAXACUM OFFICINALE", "strength": "3 [hp_X]/mL"}, {"name": "USTILAGO MAYDIS", "strength": "6 [hp_X]/mL"}, {"name": "VACCINIA VIRUS", "strength": "30 [hp_C]/mL"}, {"name": "VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN", "strength": "30 [hp_C]/mL"}, {"name": "VIROLA SEBIFERA RESIN", "strength": "6 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_end_date": "20270427", "marketing_start_date": "20220321"}