FDA.reportPublic FDA data

Colotox

Product NDC
43857-0801
11-digit product format
438570801
Labeler code
43857
Product ID
43857-0801_9cfee475-afb6-479b-a552-240f97fb29a7
Type
HUMAN OTC DRUG
Nonproprietary name
Alfalfa, Berberis Vulgaris, Rhamnus Purshiana, Rheum (Palmatum), Taraxacum Officinale, Hepar Bovine, Small Intestine (Suis), Aranea Diadema, Carbo Animalis, Carbo Vegetabilis, CINA, Mercurius Solubilis, Podophyllum Peltatum, Selenium Metallicum, Spigelia Anthelmia, Veratrum Album, Bilirubin, Creatine, Creatinine, Indolum, Skatolum, Proteus (Mirabilis), Morgan Gaertner
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-01-20
Substance
ACTIVATED CHARCOAL; ARANEUS DIADEMATUS; ARTEMISIA CINA PRE-FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BILIRUBIN; CARBO ANIMALIS; CREATINE; CREATININE; FRANGULA PURSHIANA BARK; HEPARIN, BOVINE; INDOLE; MEDICAGO SATIVA WHOLE; MERCURIUS SOLUBILIS; PODOPHYLLUM; PROTEUS MIRABILIS; RHEUM PALMATUM ROOT; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SELENIUM; SKATOLE; SPIGELIA ANTHELMIA WHOLE; SUS SCROFA INTESTINAL MUCOSA; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT
Active strength
12; 12; 12; 3; 15; 12; 15; 15; 3; 8; 15; 3; 12; 12; 20; 3; 12; 12; 15; 12; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Colotox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDICAGO SATIVA WHOLE3 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
FRANGULA PURSHIANA BARK3 [hp_X]/mL
RHEUM PALMATUM ROOT3 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
HEPARIN, BOVINE8 [hp_X]/mL
SUS SCROFA INTESTINAL MUCOSA8 [hp_X]/mL
ARANEUS DIADEMATUS12 [hp_X]/mL
CARBO ANIMALIS12 [hp_X]/mL
ACTIVATED CHARCOAL12 [hp_X]/mL
ARTEMISIA CINA PRE-FLOWERING TOP12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
PODOPHYLLUM12 [hp_X]/mL
SELENIUM12 [hp_X]/mL
SPIGELIA ANTHELMIA WHOLE12 [hp_X]/mL
VERATRUM ALBUM ROOT12 [hp_X]/mL
BILIRUBIN15 [hp_X]/mL
CREATINE15 [hp_X]/mL
CREATININE15 [hp_X]/mL
INDOLE15 [hp_X]/mL
SKATOLE15 [hp_X]/mL
PROTEUS MIRABILIS20 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS12 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 23 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DJO934BRBDInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
4VBP01X99FInternal UNII lookup
G025DAL7CEInternal UNII lookup
39981FM375Internal UNII lookup
P776JQ4R2FInternal UNII lookup
S61JFZ33Z1Internal UNII lookup
6T6CO7R3Z5Internal UNII lookup
279O8I0433Internal UNII lookup
2P3VWU3H10Internal UNII lookup
28M1820ACTInternal UNII lookup
324Y4038G2Internal UNII lookup
2S713A4VP3Internal UNII lookup
H6241UJ22BInternal UNII lookup
WYT05213GEInternal UNII lookup
QNS6W5US1ZInternal UNII lookup
RFM9X3LJ49Internal UNII lookup
MU72812GK0Internal UNII lookup
AYI8EX34EUInternal UNII lookup
8724FJW4M5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
20e20965-61db-44a3-82bf-f1ca18e6b6bcAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0801-1Colotox30 mL in 1 BOTTLE, DROPPERLIQUID301

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, MERCURIUS SOLUBILIS, PODOPHYLLUM PELTATUM, SELENIUM METALLICUM, SPIGELIA ANTHELMIA, VERATRUM ALBUM, BILIRUBIN, CREATINE, CREATININE, INDOLUM, SKATOLUM, PROTEUS (MIRABILIS), MORGAN GAERTNERBioActive Nutritional, Inc.20e20965-61db-44a3-82bf-f1ca18e6b6bc2026-01-20WarningsExact identifier
ndc (product): 43857-0801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0801-14385708010130 mL in 1 BOTTLE, DROPPER (43857-0801-1) 30 ml2026-01-20NoNoCurrent