FDA.reportPublic FDA data

Neurotox

Product NDC
43857-0632
11-digit product format
438570632
Labeler code
43857
Product ID
43857-0632_28bfacec-d5ea-4620-86c1-76c2d6200295
Type
HUMAN OTC DRUG
Nonproprietary name
Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide,
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-08-09
Marketing end
2028-05-25
Substance
ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; 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; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROTEUS MORGANII; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM NITRITE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TOXICODENDRON PUBESCENS LEAF; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC
Active strength
12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 15; 12; 12; 12; 12; 12; 30; 12; 12; 30; 12; 12; 12; 30; 12; 30; 30; 30; 30; 12; 14; 30; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 12; 30; 12; 12; 12; 30; 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_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_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_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
Pharmacologic classes
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neurotox

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM12 [hp_X]/mL
AMANITA MUSCARIA FRUITING BODY12 [hp_X]/mL
ANTIMONY TRISULFIDE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BARIUM CARBONATE12 [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
CADMIUM12 [hp_X]/mL
CERIUM12 [hp_X]/mL
CESIUM CHLORIDE12 [hp_X]/mL
CHROMIUM12 [hp_X]/mL
CITHARACANTHUS SPINICRUS30 [hp_X]/mL
CLOSTRIDIUM PERFRINGENS15 [hp_C]/mL
COBALT12 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP12 [hp_X]/mL
COPPER12 [hp_X]/mL
DYSPROSIUM12 [hp_X]/mL
ERBIUM12 [hp_X]/mL
ESCHERICHIA COLI30 [hp_X]/mL
EUROPIUM12 [hp_X]/mL
GADOLINIUM12 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT30 [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
LATRODECTUS MACTANS30 [hp_X]/mL
LEAD12 [hp_X]/mL
LITHIUM CARBONATE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MAGNESIUM12 [hp_X]/mL
MANGANESE12 [hp_X]/mL
MEASLES VIRUS30 [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
PHOSPHORUS12 [hp_X]/mL
PLATINUM12 [hp_X]/mL
POLIOVIRUS30 [hp_C]/mL
PRASEODYMIUM12 [hp_X]/mL
PROTEUS MORGANII30 [hp_X]/mL
PROTEUS VULGARIS30 [hp_X]/mL
PROTORTONIA CACTI12 [hp_X]/mL
PSEUDOMONAS AERUGINOSA30 [hp_X]/mL
RHODIUM12 [hp_X]/mL
RUBIDIUM NITRITE12 [hp_X]/mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI33 [hp_X]/mL
SAMARIUM12 [hp_X]/mL
SELENIUM12 [hp_X]/mL
SILVER12 [hp_X]/mL
STRONTIUM CARBONATE12 [hp_X]/mL
TANTALUM30 [hp_C]/mL
TERBIUM12 [hp_X]/mL
THALLIUM12 [hp_X]/mL
TIN12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF30 [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
UniiCPD4NFA903, DIF093I037, F79059A38U, S7V92P67HO, 6P669D8HQ8, OW5102UV6N, U015TT5I8H, N9E3X5056Q, E211KPY694, SBV4XY874G, 00BH33GNGH, 30K4522N6T, GNR9HML8BA, 0R0008Q3JB, 3Y5X6RT823, OVP6XX033E, 3G0H8C9362, Q28R5GF371, 789U1901C5, 1D4N45714Q

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0632-1Neurotox60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0632NEUROTOX (AGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE,) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, 1 package rows20250521_07a457c0-df0d-468a-b0d8-84c739c17b70.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0632-14385706320160 mL in 1 BOTTLE, DROPPER (43857-0632-1) 60 ml2023-08-092028-05-25NoNoHistorical