FDA.reportPublic FDA data

Systemic Detox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:17

Label at a glance#

ProductSystemic Detox
Active ingredientBERBERIS VULGARIS ROOT BARK, PEUMUS BOLDUS LEAF, CHELIDONIUM MAJUS WHOLE, ARCTIUM LAPPA ROOT, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE FLOWER, GOLDENSEAL, MARSDENIA CONDURANGO BARK, GINKGO, TABEBUIA IMPETIGINOSA BARK, CONIUM MACULATUM FLOWERING TOP, CALCIUM SULFIDE, LYCOPODIUM CLAVATUM SPORE, SMILAX ORNATA ROOT, ALOE, ECHINACEA ANGUSTIFOLIA WHOLE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, THUJA OCCIDENTALIS LEAFY TWIG
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

Berberis Vulgaris 3X, Boldo 3X, Chelidonium Majus 3X, Lappa Major 3X, Taraxacum Officinale 3X, Trifolium Pratense 3X, Hydrastis Canadensis 5X, Condurango 6X, Ginkgo Biloba 6X, Tabebuia Impetiginosa 6X, Conium Maculatum 12X, Hepar Sulphuris Calcareum 12X, Lycopodium Clavatum 12X, Sarsaparilla (Smilax Regelii) 12X, Aloe 30X, Echinacea (Angustifolia) 30X, Natrum Sulphuricum 30X, Nux Vomica 30X, Thuja Occidentalis 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.

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 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

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 diarrhea (painless, clay colored); eczema with itching; hay fever, offensive discharge running from the nose, and dyspepsia with bitter taste.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

SYSTEMIC DETOX

HOMEOPATHIC

1 FL OZ (30 ml)

Systemic DetoxSystemic Detox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0435-12024-10-18C16284748780-19d75b9d0-ae04-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0435-12020-01-31C16284748780-19d75b9d0-ae04-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0435-1Systemic Detox30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0435SYSTEMIC DETOX (BERBERIS VULGARIS, BOLDO, CHELIDONIUM MAJUS, LAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, CONDURANGO, GINKGO BILOBA, TABEBUIA IMPETIGINOSA, CONIUM MACULATUM, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SARSAPARILLA (SMILAX REGELII), ALOE, ECHINACEA (ANGUSTIFOLIA), NATRUM SULPHURICUM, NUX VOMICA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241020_2cf7a85a-bc21-4aec-9901-d60b10086df3.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-043543857-0435-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
GOLDENSEALZW3Z11D0JVACTIB
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB
GINKGO19FUJ2C58TACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
ALOEV5VD430YW9ACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
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
Systemic DetoxBERBERIS VULGARIS, BOLDO, CHELIDONIUM MAJUS, LAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, CONDURANGO, GINKGO BILOBA, TABEBUIA IMPETIGINOSA, CONIUM MACULATUM, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SARSAPARILLA (SMILAX REGELII), ALOE, ECHINACEA (ANGUSTIFOLIA), NATRUM SULPHURICUM, NUX VOMICA, THUJA OCCIDENTALISBioActive Nutritional, Inc.2cf7a85a-bc21-4aec-9901-d60b10086df32024-10-18WarningsExact identifier
ndc (package): 43857-0435-1
ndc (product): 43857-0435
ndc11 (package): 43857043501
spl id: 5eb3c159-5736-4d21-8380-23a832f20efc
spl set id: 2cf7a85a-bc21-4aec-9901-d60b10086df3

Reported adverse events (FAERS/openFDA)#

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