Additox

Product NDC
43857-0487
11-digit product format
438570487
Labeler code
43857
Product ID
43857-0487_e095c202-fcfe-4cc8-8985-4e6c3a0f35b0
Type
HUMAN OTC DRUG
Nonproprietary name
Trifolium Pratense, Xanthoxylum Fraxineum, Phytolacca Decandra, Arsenicum Album, Belladonna, Chelidonium Majus, Lycopodium Clavatum, Phosphoricum Acidum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methylparaben, Propylparaben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-07-18
Substance
TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3; 3; 4; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [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
Pharmacologic classes
Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Coagulation Factor Activity [PE], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrogen Binding Agent [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Additox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFOLIUM PRATENSE FLOWER3 [hp_X]/mL
ZANTHOXYLUM AMERICANUM BARK3 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT4 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
ATROPA BELLADONNA12 [hp_X]/mL
CHELIDONIUM MAJUS12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
ASPARTAME30 [hp_X]/mL
BENZALKONIUM CHLORIDE30 [hp_X]/mL
FORMALDEHYDE30 [hp_X]/mL
METHYLENE CHLORIDE30 [hp_X]/mL
METHYLPARABEN30 [hp_X]/mL
PROPYLPARABEN30 [hp_X]/mL
SODIUM BENZOATE30 [hp_X]/mL
SODIUM CITRATE30 [hp_X]/mL
TITANIUM DIOXIDE30 [hp_X]/mL
ZINC OXIDE30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4JS0838828Internal UNII lookup
A4KL1HMZ7TInternal UNII lookup
11E6VI8VEGInternal UNII lookup
S7V92P67HOInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
7E889U5RNNInternal UNII lookup
C88X29Y479Internal UNII lookup
E4GA8884NNInternal UNII lookup
Z0H242BBR1Internal UNII lookup
F5UM2KM3W7Internal UNII lookup
1HG84L3525Internal UNII lookup
588X2YUY0AInternal UNII lookup
A2I8C7HI9TInternal UNII lookup
Z8IX2SC1OHInternal UNII lookup
OJ245FE5EUInternal UNII lookup
1Q73Q2JULRInternal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
319ee2fe-58e3-495e-bf0d-df201f6fbb1cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0487-1Additox30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0487ADDITOX (TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, Legacy NDC, 1 package rows20180720_319ee2fe-58e3-495e-bf0d-df201f6fbb1c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
ndc (product): 43857-0487

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0487-14385704870130 mL in 1 BOTTLE, DROPPER (43857-0487-1) 30 ml2018-07-180000-00-00NoNoCurrent