Bio-Immune

Product NDC
44911-0653
Requested package NDC
44911-0653-1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Bio-Immune

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS WHOLE10 [hp_C]/mL
LOBELIA INFLATA WHOLE30 [hp_C]/mL
RUMEX CRISPUS ROOT30 [hp_C]/mL
SAMBUCUS NIGRA FLOWERING TOP30 [hp_C]/mL
POLYGALA SENEGA ROOT30 [hp_C]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED30 [hp_C]/mL
TARAXACUM OFFICINALE12 [hp_X]/mL
VIROLA SEBIFERA RESIN3 [hp_X]/mL
LOBARIA PULMONARIA10 [hp_C]/mL
SULFUR30 [hp_C]/mL
USTILAGO MAYDIS12 [hp_X]/mL
LARICIFOMES OFFICINALIS FRUITING BODY30 [hp_C]/mL
CANDIDA ALBICANS30 [hp_C]/mL
MILK THISTLE30 [hp_C]/mL
CROTALUS HORRIDUS HORRIDUS VENOM30 [hp_C]/mL
SCROPHULARIA NODOSA WHOLE30 [hp_C]/mL
AMANITA MUSCARIA FRUITING BODY8 [hp_X]/mL
LYCOPERDON UTRIFORME FRUITING BODY6 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM3 [hp_X]/mL
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE10 [hp_C]/mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT12 [hp_X]/mL
ARSENIC TRIOXIDE3 [hp_X]/mL
BAPTISIA TINCTORIA ROOT30 [hp_C]/mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
CLOSTRIDIUM BOTULINUM30 [hp_C]/mL
SHIGELLA DYSENTERIAE3 [hp_X]/mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS12 [hp_X]/mL
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)30 [hp_C]/mL
INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)3 [hp_X]/mL
INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)30 [hp_C]/mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)6 [hp_X]/mL
VACCINIA VIRUS3 [hp_X]/mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED6 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE30 [hp_C]/mL
RANCID BEEF30 [hp_C]/mL
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 36 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7E889U5RNNInternal UNII lookup
9PP1T3TC5UInternal UNII lookup
9N1RM2S62CInternal UNII lookup
CT03BSA18UInternal UNII lookup
M7T6H7D4IFInternal UNII lookup
1PIP394IIDInternal UNII lookup
39981FM375Internal UNII lookup
GHJ5XX5SGSInternal UNII lookup
D1YM0P5Z2TInternal UNII lookup
70FD1KFU70Internal UNII lookup
4K7Z7K7SWGInternal UNII lookup
7IFM8431X3Internal UNII lookup
4D7G21HDBCInternal UNII lookup
U946SH95EEInternal UNII lookup
YHA2XLJ956Internal UNII lookup
7H443NUB2TInternal UNII lookup
DIF093I037Internal UNII lookup
K2A74U428FInternal UNII lookup
01G9XEA93NInternal UNII lookup
RN2HC612GYInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f3e6e90-3495-4dee-93d2-1a272b075125Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-10-24DRUG FACTS:
2024-10-24DRUG FACTS:
2024-01-30DRUG FACTS:
2024-01-30DRUG 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio-ImmuneCHELIDONIUM 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),Energique, Inc.5f3e6e90-3495-4dee-93d2-1a272b0751252025-10-06WarningsExact identifier
ndc (package): 44911-0653-1
ndc (product): 44911-0653
ndc11 (package): 44911065301

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