Renotox
- Product NDC
- 43857-0582
- 11-digit product format
- 438570582
- Labeler code
- 43857
- Product ID
- 43857-0582_a813310b-deea-4938-9fd1-0f4512d3d491
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Triticum Aestivum, Asparagus Officinalis, Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Barosma (Betulina), Eupatorium Purpureum, Kidney (Suis), Bryonia (Alba), Mercurius Corrosivus, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum,
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2021-05-21
- Marketing end
- 2027-01-11
- Substance
- AGATHOSMA BETULINA LEAF; ALUMINUM; ANTIMONY TRISULFIDE; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; ASPARAGUS; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; BRYONIA ALBA ROOT; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLOSTRIDIUM PERFRINGENS; COBALT; COPPER; DYSPROSIUM; ECHINACEA ANGUSTIFOLIA WHOLE; ERBIUM; ESCHERICHIA COLI; EUROPIUM; EUTROCHIUM PURPUREUM ROOT; GADOLINIUM; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INDIUM; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IRON; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PETROSELINUM CRISPUM WHOLE; PLATINUM; POLIOVIRUS; PORK KIDNEY; POTASSIUM CHLORIDE; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SAW PALMETTO; SELENIUM; SILVER; SOLIDAGO VIRGAUREA FLOWERING TOP; STRONTIUM CARBONATE; TANTALUM; TARAXACUM OFFICINALE; TERBIUM; THALLIUM; TIN; TRITICUM AESTIVUM WHOLE; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC
- Active strength
- 5; 12; 12; 3; 12; 3; 12; 3; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 15; 12; 12; 12; 3; 12; 30; 12; 6; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 12; 12; 3; 12; 30; 8; 3; 12; 30; 30; 30; 12; 12; 33; 12; 3; 12; 12; 3; 12; 30; 3; 12; 12; 12; 1; 12; 12; 12; 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_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; [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; [hp_C]/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_C]/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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Mood Stabilizer [EPC], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Renotox
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRITICUM AESTIVUM WHOLE | 5 [hp_X]/mL |
| ASPARAGUS | 12 [hp_X]/mL |
| BERBERIS VULGARIS ROOT BARK | 12 [hp_X]/mL |
| ECHINACEA ANGUSTIFOLIA WHOLE | 3 [hp_X]/mL |
| POTASSIUM CHLORIDE | 12 [hp_X]/mL |
| PETROSELINUM CRISPUM WHOLE | 3 [hp_X]/mL |
| SAW PALMETTO | 12 [hp_X]/mL |
| SOLIDAGO VIRGAUREA FLOWERING TOP | 3 [hp_X]/mL |
| TARAXACUM OFFICINALE | 12 [hp_X]/mL |
| ARCTOSTAPHYLOS UVA-URSI LEAF | 12 [hp_X]/mL |
| AGATHOSMA BETULINA LEAF | 12 [hp_X]/mL |
| EUTROCHIUM PURPUREUM ROOT | 30 [hp_X]/mL |
| PORK KIDNEY | 12 [hp_X]/mL |
| BRYONIA ALBA ROOT | 12 [hp_X]/mL |
| MERCURIC CHLORIDE | 12 [hp_X]/mL |
| ALUMINUM | 12 [hp_X]/mL |
| ANTIMONY TRISULFIDE | 12 [hp_X]/mL |
| SILVER | 12 [hp_X]/mL |
| ARSENIC TRIOXIDE | 15 [hp_C]/mL |
| GOLD | 12 [hp_X]/mL |
| BARIUM CARBONATE | 12 [hp_X]/mL |
| BERYLLIUM | 12 [hp_X]/mL |
| BISMUTH | 3 [hp_X]/mL |
| BORON | 12 [hp_X]/mL |
| BROMINE | 30 [hp_X]/mL |
| CADMIUM | 12 [hp_X]/mL |
| CERIUM | 6 [hp_X]/mL |
| CESIUM CHLORIDE | 12 [hp_X]/mL |
| CHROMIUM | 12 [hp_X]/mL |
| COBALT | 12 [hp_X]/mL |
| COPPER | 12 [hp_X]/mL |
| DYSPROSIUM | 30 [hp_C]/mL |
| ERBIUM | 12 [hp_X]/mL |
| EUROPIUM | 30 [hp_X]/mL |
| IRON | 30 [hp_X]/mL |
| GADOLINIUM | 30 [hp_X]/mL |
| GERMANIUM SESQUIOXIDE | 30 [hp_X]/mL |
| HOLMIUM | 12 [hp_X]/mL |
| INDIUM | 14 [hp_C]/mL |
| LITHIUM CARBONATE | 12 [hp_X]/mL |
| MAGNESIUM | 12 [hp_X]/mL |
| MANGANESE | 12 [hp_X]/mL |
| MERCURIUS SOLUBILIS | 12 [hp_X]/mL |
| MOLYBDENUM | 30 [hp_X]/mL |
| NEODYMIUM OXIDE | 12 [hp_X]/mL |
| NICKEL | 12 [hp_X]/mL |
| OSMIUM | 12 [hp_X]/mL |
| PALLADIUM | 12 [hp_X]/mL |
| PLATINUM | 12 [hp_X]/mL |
| LEAD | 30 [hp_C]/mL |
| PRASEODYMIUM | 12 [hp_X]/mL |
| RHODIUM | 12 [hp_X]/mL |
| RUBIDIUM NITRITE | 3 [hp_X]/mL |
| SAMARIUM | 12 [hp_X]/mL |
| SELENIUM | 30 [hp_C]/mL |
| TIN | 8 [hp_X]/mL |
| STRONTIUM CARBONATE | 3 [hp_X]/mL |
| TERBIUM | 12 [hp_X]/mL |
| THALLIUM | 30 [hp_X]/mL |
| URANYL NITRATE HEXAHYDRATE | 30 [hp_X]/mL |
| VANADIUM | 30 [hp_X]/mL |
| YTTERBIUM OXIDE | 12 [hp_X]/mL |
| ZINC | 12 [hp_X]/mL |
| INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) | 33 [hp_X]/mL |
| INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 12 [hp_X]/mL |
| INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) | 3 [hp_X]/mL |
| INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) | 12 [hp_X]/mL |
| MEASLES VIRUS | 12 [hp_X]/mL |
| BOTULINUM TOXIN TYPE A | 3 [hp_X]/mL |
| ESCHERICHIA COLI | 12 [hp_X]/mL |
| PROTEUS VULGARIS | 30 [hp_C]/mL |
| PSEUDOMONAS AERUGINOSA | 3 [hp_X]/mL |
| PROTEUS MORGANII | 12 [hp_X]/mL |
| SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI | 12 [hp_X]/mL |
| LANTHANUM | 12 [hp_X]/mL |
| CLOSTRIDIUM PERFRINGENS | 1 [hp_X]/mL |
| HUMAN HERPESVIRUS 4 | 12 [hp_X]/mL |
| NIOBIUM | 12 [hp_X]/mL |
| POLIOVIRUS | 12 [hp_X]/mL |
| TANTALUM | 12 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3C3Y389JBU | Internal UNII lookup |
| Z1EJP3037Z | Internal UNII lookup |
| 1TH8Q20J0U | Internal UNII lookup |
| VB06AV5US8 | Internal UNII lookup |
| 660YQ98I10 | Internal UNII lookup |
| 1WZA4Y92EX | Internal UNII lookup |
| J7WWH9M8QS | Internal UNII lookup |
| 5405K23S50 | Internal UNII lookup |
| 39981FM375 | Internal UNII lookup |
| 3M5V3D1X36 | Internal UNII lookup |
| 369DDH39Z0 | Internal UNII lookup |
| 0VYG5PVN5Q | Internal UNII lookup |
| X7BCI5P86H | Internal UNII lookup |
| T7J046YI2B | Internal UNII lookup |
| 53GH7MZT1R | Internal UNII lookup |
| CPD4NFA903 | Internal UNII lookup |
| F79059A38U | Internal UNII lookup |
| 3M4G523W1G | Internal UNII lookup |
| S7V92P67HO | Internal UNII lookup |
| 79Y1949PYO | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b501f7bc-fa3a-494e-bf95-6779a3169a49 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43857-0582-1 | 2023-11-17 | C162847 | 48780-1 | f386c649-fbda-0266-e053-dadaa90a7c1a | DRUG FACTS: |
| 43857-0582-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-fbda-0266-e053-dadaa90a7c1a | DRUG FACTS: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43857-0582-1 | Renotox | 60 mL in 1 BOTTLE, DROPPER | LIQUID | 60 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43857-0582 | RENOTOX (TRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231118_b501f7bc-fa3a-494e-bf95-6779a3169a49.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Renotox | TRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, | BioActive Nutritional, Inc. | b501f7bc-fa3a-494e-bf95-6779a3169a49 | 2023-11-17 | Warnings | 43857-0582 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43857-0582-1 | 43857058201 | 60 mL in 1 BOTTLE, DROPPER (43857-0582-1) | 60 ml | 2021-05-21 | 2027-01-11 | No | No | Current |