FDA.reportPublic FDA data

Envirotox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-03-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:26:28

Label at a glance#

ProductEnvirotox
Active ingredientTRITICUM AESTIVUM WHOLE, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, FRANGULA PURSHIANA BARK, SENNA LEAF, PHYTOLACCA AMERICANA ROOT, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE FLOWER, ZANTHOXYLUM AMERICANUM BARK, ACETONE, SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM, PROPYLENE GLYCOL, BENZENE, AMMONIUM CHLORIDE, SODIUM LAURYL SULFATE, TURPENTINE OIL, ATROPA BELLADONNA WHOLE, LYCOPODIUM CLAVATUM SPORE, NITRIC ACID, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID
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

Triticum Aestivum 1X, Berberis Vulgaris 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Senna (Cassia Angustifolia) 3X, Phytolacca Decandra 4X, Glycyrrhiza Glabra 6X, Stillingia Sylvatica 6X, Trifolium Pratense 6X, Xanthoxylum Fraxineum 6X, Acetonum Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Belladonna 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of head congestion & general exhaustion as a consequence of exposure to smog, dust, or industrial agents.

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

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 head congestion & general exhaustion as a consequence of exposure to smog, dust, or industrial agents.

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

ENVIROTOX

HOMEOPATHIC

1 FL OZ (30 ml)

EnvirotoxEnvirotox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0625-12024-03-26C16284748780-11030e365-0cef-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0625-12024-01-30C16284748780-11030e365-0cef-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0625-1Envirotox30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0625ENVIROTOX (TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240328_2b5cfdba-cf4d-4eb0-8c60-20eac6922663.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-062543857-0625-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRITICUM AESTIVUM WHOLE3C3Y389JBUACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
SENNA LEAFAK7JF626KXACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
STILLINGIA SYLVATICA ROOTQBR70R4FBKACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
ACETONE1364PS73AFACTIB
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM5HK03SA80JACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
BENZENEJ64922108FACTIB
AMMONIUM CHLORIDE01Q9PC255DACTIM
SODIUM LAURYL SULFATE368GB5141JACTIB
TURPENTINE OILC5H0QJ6V7FACTIB
ATROPA BELLADONNA WHOLEDSV74G1P2JACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
NITRIC ACID411VRN1TV4ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
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
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
ndc (package): 43857-0625-1
ndc (product): 43857-0625
ndc11 (package): 43857062501
spl id: f359d4a8-911a-474e-9755-5c504eb32011
spl set id: 2b5cfdba-cf4d-4eb0-8c60-20eac6922663

Reported adverse events (FAERS/openFDA)#

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