FDA.reportPublic FDA data

Bio-Immune

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:01

Label at a glance#

ProductBio-Immune
Active ingredientCHELIDONIUM MAJUS WHOLE, LOBELIA INFLATA WHOLE, RUMEX CRISPUS ROOT, SAMBUCUS NIGRA FLOWERING TOP, POLYGALA SENEGA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, TARAXACUM OFFICINALE, VIROLA SEBIFERA RESIN, LOBARIA PULMONARIA, SULFUR, USTILAGO MAYDIS, LARICIFOMES OFFICINALIS FRUITING BODY, CANDIDA ALBICANS, MILK THISTLE, CROTALUS HORRIDUS HORRIDUS VENOM, SCROPHULARIA NODOSA WHOLE, AMANITA MUSCARIA FRUITING BODY, LYCOPERDON UTRIFORME FRUITING BODY, CLAVICEPS PURPUREA SCLEROTIUM, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BERBERIS VULGARIS ROOT BARK, CLOSTRIDIUM BOTULINUM, SHIGELLA DYSENTERIAE, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS, INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), VACCINIA VIRUS, HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED, STREPTOCOCCUS PNEUMONIAE, RANCID BEEF, VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop) 3.97% of Myristica Sebifera 6X, Sticta Pulmonaria 6X, Sulphur 6X, Ustilago Maidis 6X; Candida Albicans 12X, Carduus Marianus 12X, Crotalus Horridus 12X, Scrophularia Nodosa 12X; Agaricus Muscarius 10C, Bovista 10C, Secale Cornutum 10C; Anas Barbariae, Hepatis ET Cordis Extractum 30C, Anthracinum 30C, Arsenicum Album 30C, Baptisia Tinctoria 30C, Berberis Vulgaris 30C, Botulinum 30C, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C, Influenzinum (2021-2022) 30C, Malandrinum 30C, Pertussinum 30C, Pneumococcinum 30C, Pyrogenium 30C, Variolinum 30C. 0.10% of Chelidonium Majus 3X, Lobelia Inflata 3X, Rumex Crispus 3X, Sambucus Nigra 3X, Senega Officinalis 3X, Spongia Tosta 3X, Taraxacum Officinale 3X; Polyporus Officinalis 8X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms of fever, cough, swollen glands, or diarrhea.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms of fever, cough, swollen glands, or diarrhea.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc., 201 Apple Blvd.
Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

BIO-IMMUNE

1 fl. oz. (30 ml)

Bio-ImmuneBio-Immune

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363113700602GTIN-13: 0363113700602
EAN-13: 0363113700602
GTIN-12: 363113700602
UPC-A: 363113700602
GTIN storage (14 digits): 00363113700602		ENRG0560 Bio-Immune 2-7-22.jpg

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-065344911-0653-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
LOBELIA INFLATA WHOLE9PP1T3TC5UACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
POLYGALA SENEGA ROOTM7T6H7D4IFACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
VIROLA SEBIFERA RESINGHJ5XX5SGSACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
SULFUR70FD1KFU70ACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
LARICIFOMES OFFICINALIS FRUITING BODY7IFM8431X3ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
MILK THISTLEU946SH95EEACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
SCROPHULARIA NODOSA WHOLE7H443NUB2TACTIB
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
LYCOPERDON UTRIFORME FRUITING BODYK2A74U428FACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATERN2HC612GYACTIB
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CLOSTRIDIUM BOTULINUM0296055VE0ACTIB
SHIGELLA DYSENTERIAE1EP6R5562JACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDISY3V16D4PV4ACTIB
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)WD5E5VYM2EACTIB
INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)V529EJB2CXACTIB
INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)VEH9U90EHXACTIB
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)B93BQX9789ACTIB
VACCINIA VIRUSJDS6958QAGACTIB
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTEDU364V64HUNACTIB
STREPTOCOCCUS PNEUMONIAEBT6U234YR2ACTIB
RANCID BEEF29SUH5R3HUACTIB
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN4SV59689SKACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-24full-release2026-06-01 02:28:26

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
spl id: 5022d2ed-631e-4d4c-89b9-5d80e48e8c5b
spl set id: 5f3e6e90-3495-4dee-93d2-1a272b075125

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.