FDA.reportPublic FDA data

Chemtox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:28:15

Label at a glance#

ProductChemtox
Active ingredientTRITICUM AESTIVUM WHOLE, BERBERIS VULGARIS ROOT BARK, GLYCYRRHIZA GLABRA, ARCTIUM LAPPA ROOT, FRANGULA ALNUS BARK, FRANGULA PURSHIANA BARK, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE FLOWER, ZANTHOXYLUM AMERICANUM BARK, PHYTOLACCA AMERICANA ROOT, SUS SCROFA ADRENAL GLAND, PORK LIVER, SUS SCROFA LYMPH, THYROID, ATROPA BELLADONNA WHOLE, LYCOPODIUM CLAVATUM SPORE, NITRIC ACID, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SALICYLIC ACID, CORTISONE ACETATE, EUGENOL, STEARYL ALCOHOL, XYLITOL, ESTRONE, BENZOIC ACID, CHLORINE, POTASSIUM SORBATE, SORBITOL, RESORCINOL, BENZYL ALCOHOL, LACTIC ACID, DL-, ISOPROPYL PALMITATE, BORIC ACID, ACETIC ACID, PHENYLBUTAZONE, PETROLATUM, LEAD, CORTICOTROPIN
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 MT, Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Frangula 3X, Rhamnus Purshiana 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Phytolacca Decandra 4X, Glandula Suprarenalis Suis 8X, Hepar Suis 8X, Lymph (Suis) 8X, Thyroidinum (Suis) 8X, Belladonna 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Salicylicum Acidum 30X, 60X, 200X, Cortisone Aceticum 30X, 60X, 200X, Eugenol 30X, 60X, 200X, Stearyl Alcohol 30X, 60X, 200X, Xylitol 30X, 60X, 200X, Folliculinum 30X, 60X, 200X, Benzoicum Acidum 30X, 60X, 200X, Chlorinum 30X, 60X, 200X, Potassium Sorbate 30X, 60X, 200X, Sorbitol 30X, 60X, 200X, Resorcinum 30X, 60X, 200X, Benzyl Alcohol 30X, 60X, 200X, Lacticum Acidum 30X, 60X, 200X, Isopropyl Palmitate 30X, 60X, 200X, Boricum Acidum 30X, 60X, 200X, Aceticum Acidum 30X, 60X, 200X, Phenyl Butazone 30X, 60X, 200X, Petroleum Jelly 30X, 60X, 200X, Plumbum Metallicum 30X, 60X, 200X, Adrenocorticotrophin 15C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of weakness & exhaustion, minor abdominal cramps & bloating, and vomiting.

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 weakness & exhaustion, minor abdominal cramps & bloating, and vomiting.

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

*For a complete list of
Chemical Isodes contact
BioActive Nutritional, Inc.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

CHEMTOX

HOMEOPATHIC

1 FL OZ (30 ml)

ChemtoxChemtox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7Product name220250121
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508
9bfd9c37-f773-6e9a-5f6b-6f5701d62adcProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0546-12023-06-08C16284748780-1ba0f9c33-2b3f-a910-e053-dadaa90a0b85Drug Facts:
43857-0546-12023-01-30C16284748780-1ba0f9c33-2b3f-a910-e053-dadaa90a0b85Drug Facts:
43857-0546-12021-12-28C16284748780-1ba0f9c33-2b3f-a910-e053-dadaa90a0b85Drug Facts:
43857-0546-12021-01-29C16284748780-1ba0f9c33-2b3f-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0546-1Chemtox30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0546CHEMTOX (TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20241019_9aa060f1-f8f6-46e6-a7d0-bd46a73f2676.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-054643857-0546-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRITICUM AESTIVUM WHOLE3C3Y389JBUACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
FRANGULA ALNUS BARKS2D77IH61RACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
STILLINGIA SYLVATICA ROOTQBR70R4FBKACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
PORK LIVER6EC706HI7FACTIB
SUS SCROFA LYMPH33A7VYU29LACTIB
THYROID6RV024OAUQACTIB
ATROPA BELLADONNA WHOLEDSV74G1P2JACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
NITRIC ACID411VRN1TV4ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
CORTISONE ACETATE883WKN7W8XACTIB
EUGENOL3T8H1794QWACTIB
STEARYL ALCOHOL2KR89I4H1YACTIB
XYLITOLVCQ006KQ1EACTIB
ESTRONE2DI9HA706AACTIB
BENZOIC ACID8SKN0B0MIMACTIB
CHLORINE4R7X1O2820ACTIB
POTASSIUM SORBATE1VPU26JZZ4ACTIB
SORBITOL506T60A25RACTIB
RESORCINOLYUL4LO94HKACTIB
BENZYL ALCOHOLLKG8494WBHACTIB
LACTIC ACID, DL-3B8D35Y7S4ACTIB
ISOPROPYL PALMITATE8CRQ2TH63MACTIB
BORIC ACIDR57ZHV85D4ACTIB
ACETIC ACIDQ40Q9N063PACTIB
PHENYLBUTAZONEGN5P7K3T8SACTIB
PETROLATUM4T6H12BN9UACTIB
LEAD2P299V784PACTIB
CORTICOTROPINK0U68Q2TXAACTIB

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
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
ndc (package): 43857-0546-1
ndc (product): 43857-0546
ndc11 (package): 43857054601
spl id: b883884e-2c8e-4cd1-b68b-331639cb0e4a
spl set id: 9aa060f1-f8f6-46e6-a7d0-bd46a73f2676

Reported adverse events (FAERS/openFDA)#

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