FDA.reportPublic FDA data

EVTOX

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:40

Label at a glance#

ProductEVTOX
Active ingredientCOCHLEARIA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA WHOLE, LOMATIUM DISSECTUM ROOT, TABEBUIA IMPETIGINOSA BARK, GOLDENSEAL, PROPOLIS WAX, SUS SCROFA ADRENAL GLAND, SUS SCROFA THYMUS, ARANEUS DIADEMATUS, IPECAC, LYCOPODIUM CLAVATUM SPORE, HYDROCHLORIC ACID, NITRIC ACID, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, HUMAN HERPESVIRUS 4
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Cochlearia Officinalis 3X, Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Glandula Suprarenalis Suis 8X, Thymus (Suis) 8X, Aranea Diadema 12X, Ipecacuanha 12X, Lycopodium Clavatum 12X, Muriaticum Acidum 12X, Nitricum Acidum 12X, Rhus Tox 12X, Silicea 12X, Epstein-Barr Virus Nosodes 30C, 60C, 200C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fever with dyspepsia and muscular aches and weakness associated with flu.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care 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

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of fever with dyspepsia and muscular aches and weakness associated with flu.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

*For a complete list of EBV Nosodes contact BioActive Nutritional, Inc.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

EVTOX

HOMEOPATHIC

1 FL OZ (30 ml)

EVTOXEVTOX

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0531-12024-04-19C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0531-12024-01-30C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0531-12022-01-24C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0531-12021-01-29C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0531-1EVTOX30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0531EVTOX (COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240420_4b518e10-9ce0-492b-92be-6025d8d7c3c6.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-053143857-0531-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCHLEARIA OFFICINALIS FLOWERING TOPM87UN67CKRACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
GOLDENSEALZW3Z11D0JVACTIB
PROPOLIS WAX6Y8XYV2NOFACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA THYMUS7B69B0BD62ACTIB
ARANEUS DIADEMATUS6T6CO7R3Z5ACTIB
IPECAC62I3C8233LACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
HYDROCHLORIC ACIDQTT17582CBACTIB
NITRIC ACID411VRN1TV4ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
HUMAN HERPESVIRUS 42A26YW7PNXACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
ndc (package): 43857-0531-1
ndc (product): 43857-0531
ndc11 (package): 43857053101
spl id: ceca8afb-2031-4f03-a426-db23da955932
spl set id: 4b518e10-9ce0-492b-92be-6025d8d7c3c6

Reported adverse events (FAERS/openFDA)#

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