Home NDC 44911-0653-1 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 date Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Bio-Immune
Active Ingredients# Ingredient, Strength table Ingredient Strength CHELIDONIUM MAJUS WHOLE 10 [hp_C]/mL LOBELIA INFLATA WHOLE 30 [hp_C]/mL RUMEX CRISPUS ROOT 30 [hp_C]/mL SAMBUCUS NIGRA FLOWERING TOP 30 [hp_C]/mL POLYGALA SENEGA ROOT 30 [hp_C]/mL SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/mL TARAXACUM OFFICINALE 12 [hp_X]/mL VIROLA SEBIFERA RESIN 3 [hp_X]/mL LOBARIA PULMONARIA 10 [hp_C]/mL SULFUR 30 [hp_C]/mL USTILAGO MAYDIS 12 [hp_X]/mL LARICIFOMES OFFICINALIS FRUITING BODY 30 [hp_C]/mL CANDIDA ALBICANS 30 [hp_C]/mL MILK THISTLE 30 [hp_C]/mL CROTALUS HORRIDUS HORRIDUS VENOM 30 [hp_C]/mL SCROPHULARIA NODOSA WHOLE 30 [hp_C]/mL AMANITA MUSCARIA FRUITING BODY 8 [hp_X]/mL LYCOPERDON UTRIFORME FRUITING BODY 6 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM 3 [hp_X]/mL CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 10 [hp_C]/mL BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 12 [hp_X]/mL ARSENIC TRIOXIDE 3 [hp_X]/mL BAPTISIA TINCTORIA ROOT 30 [hp_C]/mL BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL CLOSTRIDIUM BOTULINUM 30 [hp_C]/mL SHIGELLA DYSENTERIAE 3 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 12 [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 VIRUS 3 [hp_X]/mL HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 6 [hp_X]/mL STREPTOCOCCUS PNEUMONIAE 30 [hp_C]/mL RANCID BEEF 30 [hp_C]/mL VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 36 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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), Energique, Inc. 5f3e6e90-3495-4dee-93d2-1a272b075125 2025-10-06 Warnings Exact identifier ndc (package): 44911-0653-1 ndc (product): 44911-0653 ndc11 (package): 44911065301
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