FDA.reportPublic FDA data

1 Detoxification

Manufacturer
Biotics Research Corporation | Apotheca Company
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:51:54

Label at a glance#

Product1 Detoxification
Active ingredientTRIFOLIUM PRATENSE FLOWER, CAPSICUM, PHYTOLACCA AMERICANA ROOT, ALUMINUM, ANTIMONY TRISULFIDE, SILVER, ARSENIC TRIOXIDE, GOLD, BARIUM CARBONATE, BERYLLIUM, BISMUTH, BORON, CADMIUM, CERIUM, CESIUM CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, IRON, GADOLINIUM, GERMANIUM SESQUIOXIDE, HOLMIUM, INDIUM, LITHIUM CARBONATE, MAGNESIUM, MANGANESE, MERCURIUS SOLUBILIS, MOLYBDENUM, NEODYMIUM OXIDE, NICKEL, OSMIUM, PALLADIUM, PLATINUM, LEAD, PRASEODYMIUM, RHODIUM, RUBIDIUM NITRITE, SAMARIUM, SELENIUM, TIN, STRONTIUM CARBONATE, TERBIUM, THALLIUM, URANYL NITRATE HEXAHYDRATE, VANADIUM, YTTERBIUM OXIDE, ZINC, CORTICOTROPIN, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT, SUS SCROFA PITUITARY GLAND, ANGUILLA ROSTRATA BLOOD SERUM, TARTARIC ACID, THERIDION CURASSAVICUM, THYROID, LANTHANUM, APIS MELLIFERA, BROMINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CARBO ANIMALIS, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CONIUM MACULATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS WALLICHIANA BARK, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NIOBIUM, PHOSPHORIC ACID, PHOSPHORUS, RANCID BEEF, CLAVICEPS PURPUREA SCLEROTIUM, SULFURIC ACID, TANTALUM, ALLYLTHIOUREA, THUJA OCCIDENTALIS LEAFY TWIG, VERATRUM ALBUM ROOT, ALCOHOL, X-RAY EXPOSED (1000 RAD)
Label structure9 sections

Dosage and administration

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Trifolium Pratense 3X, 30X, Capsicum Annuum 3X, 30C, Phytolacca Decandra 4X, 30C, Aluminum Metallicum 12X, 30X, Antimonium Crudum 12X, 30X, Argentum Metallicum 12X, 30X, Arsenicum Album 12X, 30X, Aurum Metallicum 12X, 30X, Baryta Carbonica 12X, 30X, Beryllium Metallicum 12X, 30X, Bismuthum Metallicum 12X, 30X, Boron 12X, 30X, Bromium 12X, 30X, Cadmium Metallicum 12X, 30X, Cerium Metallicum 12X, 30X, Cesium Chloride 12X, 30X, Chromium Metallicum 12X, 30X, Cobaltum Metallicum 12X, 30X, Cuprum Metallicum 12X, 30X, Dysprosium Metallicum 12X, 30X, Erbium Metallicum 12X, 30X, Europium Metallicum 12X, 30X, Ferrum Metallicum 12X, 30X, Gadolinium Metallicum 12X, 30X, Germanium Sesquioxide 12X, 30X, Holmium 12X, 30X, Indium Metallicum 12X, 30X, Lanthanum Oxide 12X, 30X, Lithium Carbonicum 12X, 30X, Magnesium Metallicum 12X, 30X, Manganum Metallicum 12X, 30X, Mercurius Solubilis 12X, 30X, Molybdenum Metallicum 12X, 30X, Neodymium Metallicum 12X, 30X, Niccolum Metallicum 12X, 30X, Niobium 12X, 30X, Osmium Metallicum 12X, 30X, Palladium Metallicum 12X, 30X, Platinum Metallicum 12X, 30X, Plumbum Metallicum 12X, 30X, Praseodymium 12X, 30X, Rhodium Metallicum 12X, 30X, Rubidium Metallicum 12X, 30X, Samarium Metallicum 12X, 30X, Selenium Metallicum 12X, 30X, Stannum Metallicum 12X, 30X, Strontium Carbonicum 12X, 30X, Tantalum 12X, 30X, Terbium 12X, 30X, Thallium Metallicum 12X, 30X, Uranium Nitricum 12X, 30X, Vanadium Metallicum 12X, 30X, Ytterbium Oxide 12X, 30X, Zincum Metallicum 12X, 30X, Adrenocorticotrophin 30X, Anthracinum 30X, Hypophysis Suis 30X, Serum Anguillae 30X, Tartaricum Acidum 30X, Theridion 30X, Thyroidinum (Suis) 30X, Apis Mellifica 30C, Bromium 30C, Calcarea Carbonica 30C, Carbo Animalis 30C, Carbo Vegetabilis 30C, Carcinosin 30C, Conium Maculatum 30C, Gelsemium Sempervirens 30C, Kali Bichromicum 30C, Lachesis Mutus 30C, Natrum Phosphoricum 30C, Phosphoricum Acidum 30C, Phosphorus 30C, Pyrogenium 30C, Secale Cornutum 30C, Hoang-Nan 30C, Sulphuricum Acidum 30C, Thiosinaminum 30C, Thuja Occidentalis 30C, Veratrum Album 30C, X-Ray 30C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair.

WARNINGS:

WARNINGS SECTION

If symptoms persist or worsen, seek the advice of a healthcare professional.

Caution: Not recommended for pregnant or lactating women.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken.

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

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional.

Consult a physician for use in children under 6 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Demineralized Water, Ethanol 1.61%, Sodium Benzoate.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by

Biotics Research Corporation

Rosenberg, TX 77471 • (281) 344-0909

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biotics Research Corporation's

21ST CENTURY
HOMEOPATHICS
NDC #55146-001-01


HOMEOPATHIC REMEDY
#1
Detoxification

Supports the elimination of wastes

and toxins associated with

detoxification protocols.


Water Based
Formula

(1.61% Ethanol)
4 fl. oz.
(120 ml)

#1 Detoxification#1 Detoxification

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55146-001-012024-10-18C16284748780-1ba0f9c33-5060-a910-e053-dadaa90a0b85Drug Facts:
55146-001-012021-01-29C16284748780-1ba0f9c33-5060-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55146-0011 DETOXIFICATION (CAPSICUM ANNUUM, PHYTOLACCA DECANDRA, TRIFOLIUM PRATENSE, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM METALLICUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM OXYDATUM, FERRUM METALLICUM, GADOLINIUM OXYDATUM, GERMANIUM SESQUIOXIDE, HOLMIUM,) LIQUID [BIOTICS RESEARCH CORPORATION]3Legacy NDC20241020_c2469463-c963-4c4d-8888-3437f441c69a.zip

Products#

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

DailyMed product names page 1 of 3 · 98 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55146-00155146-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 85 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
CAPSICUM00UK7646FGACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ALUMINUMCPD4NFA903ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
SILVER3M4G523W1GACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
GOLD79Y1949PYOACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
BERYLLIUMOW5102UV6NACTIB
BISMUTHU015TT5I8HACTIB
BORONN9E3X5056QACTIB
CADMIUM00BH33GNGHACTIB
CERIUM30K4522N6TACTIB
CESIUM CHLORIDEGNR9HML8BAACTIB
CHROMIUM0R0008Q3JBACTIB
COBALT3G0H8C9362ACTIB
COPPER789U1901C5ACTIB
DYSPROSIUM1D4N45714QACTIB
ERBIUM77B218D3YEACTIB
EUROPIUM444W947O8OACTIB
IRONE1UOL152H7ACTIB
GADOLINIUMAU0V1LM3JTACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
HOLMIUMW1XX32SQN1ACTIB
INDIUM045A6V3VFXACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
MAGNESIUMI38ZP9992AACTIB
MANGANESE42Z2K6ZL8PACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
MOLYBDENUM81AH48963UACTIB
NEODYMIUM OXIDEAYT3H319PNACTIB
NICKEL7OV03QG267ACTIB
OSMIUM2E7M255OPYACTIB
PALLADIUM5TWQ1V240MACTIB
PLATINUM49DFR088MYACTIB
LEAD2P299V784PACTIB
PRASEODYMIUMNKN7EZA750ACTIB
RHODIUMDMK383DSACACTIB
RUBIDIUM NITRITE93722E7JA1ACTIB

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
5b66bb20-f71c-4e5d-bbb9-2d74762472d0c2469463-c963-4c4d-8888-3437f441c69a2024-10-18WarningsExact identifier
spl id: 5b66bb20-f71c-4e5d-bbb9-2d74762472d0
spl set id: c2469463-c963-4c4d-8888-3437f441c69a

Reported adverse events (FAERS/openFDA)#

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