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| Ingredient | Strength |
|---|
| 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 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DIF093I037, S7V92P67HO, 41LZ22DD4N, 5EF0HWI5WU, 1TH8Q20J0U, RN2HC612GY, 4D7G21HDBC, 7E889U5RNN, 01G9XEA93N, 0296055VE0, YHA2XLJ956, U364V64HUN, V529EJB2CX, WD5E5VYM2E, B93BQX9789, VEH9U90EHX, 7IFM8431X3, D1YM0P5Z2T, 9PP1T3TC5U, K2A74U428F |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44911-0653-1 | Bio-Immune | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 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),) LIQUID [ENERGIQUE, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20241027_5f3e6e90-3495-4dee-93d2-1a272b075125.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44911-0653-1 | 44911065301 | 30 mL in 1 BOTTLE, DROPPER (44911-0653-1) | 30 ml | 2022-03-21 | 2027-04-27 | No | No | Current |