FDA.reportPublic FDA data

Colotox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:37:01

Label at a glance#

ProductColotox
Active ingredientMEDICAGO SATIVA WHOLE, BERBERIS VULGARIS ROOT BARK, FRANGULA PURSHIANA BARK, RHEUM PALMATUM ROOT, TARAXACUM OFFICINALE, BEEF LIVER, SUS SCROFA INTESTINAL MUCOSA, ARANEUS DIADEMATUS, CARBO ANIMALIS, ACTIVATED CHARCOAL, ARTEMISIA CINA PRE-FLOWERING TOP, MANDRAGORA OFFICINARUM ROOT, MERCURIUS SOLUBILIS, SELENIUM, SPIGELIA ANTHELMIA WHOLE, VERATRUM ALBUM ROOT, BILIRUBIN, CREATINE, CREATININE, INDOLE, SKATOLE, PROTEUS MIRABILIS, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS
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

Alfalfa 3X, Berberis Vulgaris 3X, Rhamnus Purshiana 3X, Rheum (Palmatum) 3X, Taraxacum Officinale 3X, Hepar Bovine 8X, Small Intestine (Suis) 8X, Aranea Diadema 12X, Carbo Animalis 12X, Carbo Vegetabilis 12X, CINA 12X, Mandragora Officinarum 12X, Mercurius Solubilis 12X, Selenium Metallicum 12X, Spigelia Anthelmia 12X, Veratrum Album 12X, Bilirubin 15X, 30X, 200X, Creatine 15X, 30X, 200X, Creatinine 15X, 30X, 200X, Indolum 15X, 30X, 200X, Skatolum 15X, 30X, 200X, Proteus (Mirabilis) 20X, Morgan Gaertner 12C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of flatulence associated with constipation.

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 flatulence associated with constipation.

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

COLOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

COLOTOXCOLOTOX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0553-12024-10-17C16284748780-1d6a99b39-542a-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0553-12024-10-17C16284748780-1d6a99b39-542a-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0553-12022-01-28C16284748780-1d6a99b39-542a-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0553-12022-01-28C16284748780-1d6a99b39-542a-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0553-1Colotox30 mL in 1 BOTTLE, DROPPERLIQUID304

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
43857-055343857-0553-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDICAGO SATIVA WHOLEDJO934BRBDACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
RHEUM PALMATUM ROOTG025DAL7CEACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
BEEF LIVERW8N8R55022ACTIB
SUS SCROFA INTESTINAL MUCOSAS61JFZ33Z1ACTIB
ARANEUS DIADEMATUS6T6CO7R3Z5ACTIB
CARBO ANIMALIS279O8I0433ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
MANDRAGORA OFFICINARUM ROOTI2XCB174VBACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SELENIUMH6241UJ22BACTIB
SPIGELIA ANTHELMIA WHOLEWYT05213GEACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
BILIRUBINRFM9X3LJ49ACTIB
CREATINEMU72812GK0ACTIB
CREATININEAYI8EX34EUACTIB
INDOLE8724FJW4M5ACTIB
SKATOLE9W945B5H7RACTIB
PROTEUS MIRABILISC177VR41DVACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDISY3V16D4PV4ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-10-17full-release2026-06-01 02:28:16

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
ColotoxALFALFA, BERBERIS VULGARIS, RHAMNUS PURSHIANA, RHEUM (PALMATUM), TARAXACUM OFFICINALE, HEPAR BOVINE, SMALL INTESTINE (SUIS), ARANEA DIADEMA, CARBO ANIMALIS, CARBO VEGETABILIS, CINA, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, SELENIUM METALLICUM, SPIGELIA ANTHELMIA, VERATRUM ALBUM, BILIRUBIN, CREATINE, CREATININE, INDOLUM, SKATOLUM, PROTEUS (MIRABILIS), MORGAN GAERTNERBioActive Nutritional, Inc.ab978956-f991-4a45-8988-b8b2508bd85e2025-10-06WarningsExact identifier
ndc (package): 43857-0553-1
ndc (product): 43857-0553
ndc11 (package): 43857055301
spl id: 4211a4d6-6d18-4a1b-9f87-7ba427692cdd
spl set id: ab978956-f991-4a45-8988-b8b2508bd85e

Reported adverse events (FAERS/openFDA)#

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