Bio-Immune

Product NDC
44911-0653
11-digit product format
449110653
Labeler code
44911
Product ID
44911-0653_5022d2ed-631e-4d4c-89b9-5d80e48e8c5b
Type
HUMAN OTC DRUG
Nonproprietary 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
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-21
Marketing end
2027-04-27
Substance
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/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 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 strength
10; 30; 30; 30; 30; 30; 12; 3; 10; 30; 12; 30; 30; 30; 30; 30; 8; 6; 3; 10; 12; 3; 30; 3; 30; 3; 12; 30; 3; 30; 6; 3; 6; 30; 30; 6 [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_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
Pharmacologic 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
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bio-Immune

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANITA MUSCARIA FRUITING BODY10 [hp_C]/mL
ARSENIC TRIOXIDE30 [hp_C]/mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT30 [hp_C]/mL
BAPTISIA TINCTORIA ROOT30 [hp_C]/mL
BERBERIS VULGARIS ROOT BARK30 [hp_C]/mL
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE30 [hp_C]/mL
CANDIDA ALBICANS12 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM10 [hp_C]/mL
CLOSTRIDIUM BOTULINUM30 [hp_C]/mL
CROTALUS HORRIDUS HORRIDUS VENOM12 [hp_X]/mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED30 [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 BODY8 [hp_X]/mL
LOBARIA PULMONARIA6 [hp_X]/mL
LOBELIA INFLATA WHOLE3 [hp_X]/mL
LYCOPERDON UTRIFORME FRUITING BODY10 [hp_C]/mL
MILK THISTLE12 [hp_X]/mL
POLYGALA SENEGA ROOT3 [hp_X]/mL
RANCID BEEF30 [hp_C]/mL
RUMEX CRISPUS ROOT3 [hp_X]/mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS30 [hp_C]/mL
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/mL
SCROPHULARIA NODOSA WHOLE12 [hp_X]/mL
SHIGELLA DYSENTERIAE30 [hp_C]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE30 [hp_C]/mL
SULFUR6 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
USTILAGO MAYDIS6 [hp_X]/mL
VACCINIA VIRUS30 [hp_C]/mL
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN30 [hp_C]/mL
VIROLA SEBIFERA RESIN6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDIF093I037, S7V92P67HO, 41LZ22DD4N, 5EF0HWI5WU, 1TH8Q20J0U, RN2HC612GY, 4D7G21HDBC, 7E889U5RNN, 01G9XEA93N, 0296055VE0, YHA2XLJ956, U364V64HUN, V529EJB2CX, WD5E5VYM2E, B93BQX9789, VEH9U90EHX, 7IFM8431X3, D1YM0P5Z2T, 9PP1T3TC5U, K2A74U428F

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0653-12024-10-24C16284748780-11030e365-2666-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0653-12024-10-24C16284748780-11030e365-2666-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0653-12024-01-30C16284748780-11030e365-2666-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0653-12024-01-30C16284748780-11030e365-2666-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0653-1Bio-Immune30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0653BIO-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),) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20241027_5f3e6e90-3495-4dee-93d2-1a272b075125.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0653-14491106530130 mL in 1 BOTTLE, DROPPER (44911-0653-1) 30 ml2022-03-212027-04-27NoNoCurrent