Home NDC 43857-0553-1 Colotox
Product NDC 43857-0553
Requested package NDC 43857-0553-1
11-digit product format 438570553
Labeler code 43857
Product ID 43857-0553_4211a4d6-6d18-4a1b-9f87-7ba427692cdd
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, Mandragora Officinarum, Mercurius Solubilis, 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 2020-03-23
Marketing end 2029-10-17
Substance ACTIVATED CHARCOAL; ARANEUS DIADEMATUS; ARTEMISIA CINA PRE-FLOWERING TOP; BEEF LIVER; BERBERIS VULGARIS ROOT BARK; BILIRUBIN; CARBO ANIMALIS; CREATINE; CREATININE; FRANGULA PURSHIANA BARK; INDOLE; MANDRAGORA OFFICINARUM ROOT; MEDICAGO SATIVA WHOLE; MERCURIUS SOLUBILIS; PROTEUS MIRABILIS; RHEUM PALMATUM ROOT; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; SKATOLE; SPIGELIA ANTHELMIA WHOLE; SUS SCROFA INTESTINAL MUCOSA; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT
Active strength 12; 12; 12; 8; 3; 15; 12; 15; 15; 3; 15; 12; 3; 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
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 Active Ingredients# Ingredient, Strength table Ingredient Strength MEDICAGO SATIVA WHOLE 3 [hp_X]/mL BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL FRANGULA PURSHIANA BARK 3 [hp_X]/mL RHEUM PALMATUM ROOT 3 [hp_X]/mL TARAXACUM OFFICINALE 3 [hp_X]/mL BEEF LIVER 8 [hp_X]/mL SUS SCROFA INTESTINAL MUCOSA 8 [hp_X]/mL ARANEUS DIADEMATUS 12 [hp_X]/mL CARBO ANIMALIS 12 [hp_X]/mL ACTIVATED CHARCOAL 12 [hp_X]/mL ARTEMISIA CINA PRE-FLOWERING TOP 12 [hp_X]/mL MANDRAGORA OFFICINARUM ROOT 12 [hp_X]/mL MERCURIUS SOLUBILIS 12 [hp_X]/mL SELENIUM 12 [hp_X]/mL SPIGELIA ANTHELMIA WHOLE 12 [hp_X]/mL VERATRUM ALBUM ROOT 12 [hp_X]/mL BILIRUBIN 15 [hp_X]/mL CREATINE 15 [hp_X]/mL CREATININE 15 [hp_X]/mL INDOLE 15 [hp_X]/mL SKATOLE 15 [hp_X]/mL PROTEUS MIRABILIS 20 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 12 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 23 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43857-0553-1 Colotox 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0553 COLOTOX (ALFALFA, 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 GAERTNER) LIQUID [BIOACTIVE NUTRITIONAL, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241019_ab978956-f991-4a45-8988-b8b2508bd85e.zip
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Colotox ALFALFA, 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 GAERTNER BioActive Nutritional, Inc. ab978956-f991-4a45-8988-b8b2508bd85e 2025-10-06 Warnings Exact identifier ndc (package): 43857-0553-1 ndc (product): 43857-0553 ndc11 (package): 43857055301
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43857-0553-1 43857055301 30 mL in 1 BOTTLE, DROPPER (43857-0553-1) 30 ml 2020-03-23 2029-10-17 No No Current