FDA.reportPublic FDA data

Renotox

Product NDC
43857-0634
11-digit product format
438570634
Labeler code
43857
Product ID
43857-0634_6d85d243-0883-4fc7-bc05-87baa26df8e2
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
2023-11-16
Marketing end
2028-09-28
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/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, 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 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; 19; 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 table
IngredientStrength
AGATHOSMA BETULINA LEAF5 [hp_X]/mL
ALUMINUM12 [hp_X]/mL
ANTIMONY TRISULFIDE12 [hp_X]/mL
ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
ASPARAGUS3 [hp_X]/mL
BARIUM CARBONATE12 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
BERYLLIUM12 [hp_X]/mL
BISMUTH12 [hp_X]/mL
BORON12 [hp_X]/mL
BOTULINUM TOXIN TYPE A30 [hp_X]/mL
BROMINE12 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
CADMIUM12 [hp_X]/mL
CERIUM12 [hp_X]/mL
CESIUM CHLORIDE12 [hp_X]/mL
CHROMIUM12 [hp_X]/mL
CLOSTRIDIUM PERFRINGENS19 [hp_C]/mL
COBALT12 [hp_X]/mL
COPPER12 [hp_X]/mL
DYSPROSIUM12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
ERBIUM12 [hp_X]/mL
ESCHERICHIA COLI30 [hp_X]/mL
EUROPIUM12 [hp_X]/mL
EUTROCHIUM PURPUREUM ROOT6 [hp_X]/mL
GADOLINIUM12 [hp_X]/mL
GERMANIUM SESQUIOXIDE12 [hp_X]/mL
GOLD12 [hp_X]/mL
HOLMIUM12 [hp_X]/mL
HUMAN HERPESVIRUS 430 [hp_C]/mL
INDIUM12 [hp_X]/mL
INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)30 [hp_X]/mL
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)30 [hp_X]/mL
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)30 [hp_X]/mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)30 [hp_X]/mL
IRON12 [hp_X]/mL
LANTHANUM14 [hp_C]/mL
LEAD12 [hp_X]/mL
LITHIUM CARBONATE12 [hp_X]/mL
MAGNESIUM12 [hp_X]/mL
MANGANESE12 [hp_X]/mL
MEASLES VIRUS30 [hp_X]/mL
MERCURIC CHLORIDE12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
MOLYBDENUM12 [hp_X]/mL
NEODYMIUM OXIDE12 [hp_X]/mL
NICKEL12 [hp_X]/mL
NIOBIUM30 [hp_C]/mL
OSMIUM12 [hp_X]/mL
PALLADIUM12 [hp_X]/mL
PETROSELINUM CRISPUM WHOLE3 [hp_X]/mL
PLATINUM12 [hp_X]/mL
POLIOVIRUS30 [hp_C]/mL
PORK KIDNEY8 [hp_X]/mL
POTASSIUM CHLORIDE3 [hp_X]/mL
PRASEODYMIUM12 [hp_X]/mL
PROTEUS MORGANII30 [hp_X]/mL
PROTEUS VULGARIS30 [hp_X]/mL
PSEUDOMONAS AERUGINOSA30 [hp_X]/mL
RHODIUM12 [hp_X]/mL
RUBIDIUM NITRITE12 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI33 [hp_X]/mL
SAMARIUM12 [hp_X]/mL
SAW PALMETTO3 [hp_X]/mL
SELENIUM12 [hp_X]/mL
SILVER12 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
STRONTIUM CARBONATE12 [hp_X]/mL
TANTALUM30 [hp_C]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
TERBIUM12 [hp_X]/mL
THALLIUM12 [hp_X]/mL
TIN12 [hp_X]/mL
TRITICUM AESTIVUM WHOLE1 [hp_X]/mL
URANYL NITRATE HEXAHYDRATE12 [hp_X]/mL
VANADIUM12 [hp_X]/mL
YTTERBIUM OXIDE12 [hp_X]/mL
ZINC12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii369DDH39Z0, CPD4NFA903, F79059A38U, 3M5V3D1X36, S7V92P67HO, Z1EJP3037Z, 6P669D8HQ8, 1TH8Q20J0U, OW5102UV6N, U015TT5I8H, N9E3X5056Q, E211KPY694, SBV4XY874G, T7J046YI2B, 00BH33GNGH, 30K4522N6T, GNR9HML8BA, 0R0008Q3JB, OVP6XX033E, 3G0H8C9362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0634-1Renotox60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0634RENOTOX (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.]2Current NDC, 1 package rows20250322_f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0634-14385706340160 mL in 1 BOTTLE, DROPPER (43857-0634-1) 60 ml2023-11-162028-09-28NoNoHistorical