FDA.reportPublic FDA data

EVTOX

Product NDC
43857-0531
11-digit product format
438570531
Labeler code
43857
Product ID
43857-0531_ceca8afb-2031-4f03-a426-db23da955932
Type
HUMAN OTC DRUG
Nonproprietary name
Cochlearia Officinalis, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Aranea Diadema, Ipecacuanha, Lycopodium Clavatum, Muriaticum Acidum, Nitricum Acidum, Rhus Tox, Silicea, Epstein-Barr Virus Nosode
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-03
Substance
ARANEUS DIADEMATUS; COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF
Active strength
12; 3; 3; 5; 30; 12; 12; 3; 12; 12; 6; 12; 8; 8; 3; 12 [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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EVTOX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARANEUS DIADEMATUS12 [hp_X]/mL
COCHLEARIA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
HUMAN HERPESVIRUS 430 [hp_C]/mL
HYDROCHLORIC ACID12 [hp_X]/mL
IPECAC12 [hp_X]/mL
LOMATIUM DISSECTUM ROOT3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
NITRIC ACID12 [hp_X]/mL
PROPOLIS WAX6 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
SUS SCROFA ADRENAL GLAND8 [hp_X]/mL
SUS SCROFA THYMUS8 [hp_X]/mL
TABEBUIA IMPETIGINOSA BARK3 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6T6CO7R3Z5, M87UN67CKR, VB06AV5US8, ZW3Z11D0JV, 2A26YW7PNX, QTT17582CB, 62I3C8233L, 5329928G5N, C88X29Y479, 411VRN1TV4, 6Y8XYV2NOF, ETJ7Z6XBU4, 398IYQ16YV, 7B69B0BD62, 6GLA1946WX, 6IO182RP7A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0531-12024-04-19C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0531-12024-01-30C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0531-12022-01-24C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0531-12021-01-29C16284748780-1ba0f9c33-14b2-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0531-1EVTOX30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0531EVTOX (COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240420_4b518e10-9ce0-492b-92be-6025d8d7c3c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0531-14385705310130 mL in 1 BOTTLE, DROPPER (43857-0531-1) 30 ml2019-10-030000-00-00NoNoCurrent