FDA.reportPublic FDA data

Androtox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-08-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:21:58

Label at a glance#

ProductAndrotox
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, CENTELLA ASIATICA WHOLE, SAW PALMETTO, TABEBUIA IMPETIGINOSA BARK, THUJA OCCIDENTALIS LEAFY TWIG, ASTRAGALUS PROPINQUUS ROOT, SUS SCROFA ADRENAL GLAND, SUS SCROFA LYMPH, ZINC GLUCONATE, JUNIPERUS VIRGINIANA TWIG, MERCURIUS SOLUBILIS, SODIUM SULFATE, SUS SCROFA TESTICLE, SUS SCROFA PROSTATE, PULSATILLA PRATENSIS WHOLE, RHODODENDRON AUREUM LEAF, SPONGIA OFFICINALIS SKELETON, ROASTED, CALCIUM SULFATE ANHYDROUS, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, BOTULINUM TOXIN TYPE A, ESCHERICHIA COLI, PROTEUS VULGARIS, PSEUDOMONAS AERUGINOSA, PROTEUS MORGANII, SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Echinacea 3X, Hydrocotyle Asiatica 3X, Sabal Serrulata 3X, Tabebuia Impetiginosa 3X, Thuja Occidentalis 3X, Astragalus Membranaceus 6X, Glandula Suprarenalis Suis 6X, Lymph Node 6X, Zincum Gluconicum 6X, Juniperus Virginiana 8X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Orchitinum 12X, Prostate 12X, Pulsatilla 12X, Rhododendron Chrysanthum 12X, Spongia Tosta 12X, Calcarea Sulphurica 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Botulinum 30X, 60X, Colibacillinum Cum Natrum Muriaticum 30X, 60X, Proteus (Morgani) 30X, 60X, Proteus (Vulgaris) 30x, 60X, Pseudomonas Aeruginosa 30X, 60X, Salmonella Typhi Nosode 33X, 60X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of pain of the lower abdomen, yellow discharge from the urethra; urine passing slowly only in drops and painful urethral orifice after micturition.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of pain of the lower abdomen, yellow discharge from the urethra; urine passing slowly only in drops and painful urethral orifice after micturition.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ANDROTOX

HOMEOPATHIC

1 FL OZ (30 ml)

AndrotoxAndrotox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0523-12023-08-03C16284748780-1ba0f9c33-5b3e-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0523-12021-01-29C16284748780-1ba0f9c33-5b3e-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0523-1Androtox30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0523ANDROTOX (ECHINACEA (ANGUSTIFOLIA), HYDROCOTYLE ASIATICA, SABAL SERRULATA, TABEBUIA IMPETIGINOSA, THUJA OCCIDENTALIS, ASTRAGALUS MEMBRANACEUS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), ZINCUM GLUCONICUM, JUNIPERUS VIRGINIANA, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, ORCHITINUM (SUIS), PROSTATE (SUIS), PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, SPONGIA TOSTA, CALCAREA SULPHURICA, LYCOPODIUM CLAVATUM, PHOSPHORUS, BOTULINUM, ESCHERICHIA COLI, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, SALMONELLA TYPHINOSODE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20230804_d3f89e4d-c3a0-4481-bf0e-0413993a8bc5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-052343857-0523-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
CENTELLA ASIATICA WHOLE7M867G6T1UACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA LYMPH33A7VYU29LACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
JUNIPERUS VIRGINIANA TWIG532BCG080LACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SODIUM SULFATE0YPR65R21JACTIB
SUS SCROFA TESTICLEKM02613O28ACTIB
SUS SCROFA PROSTATEO6UD3347K2ACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
BOTULINUM TOXIN TYPE AE211KPY694ACTIB
ESCHERICHIA COLI514B9K0L10ACTIB
PROTEUS VULGARIS11T9HCO30OACTIB
PSEUDOMONAS AERUGINOSAY793W5V55NACTIB
PROTEUS MORGANII56X6LID5ZYACTIB
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI760T5R8B3OACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
AndrotoxECHINACEA (ANGUSTIFOLIA), HYDROCOTYLE ASIATICA, SABAL SERRULATA, TABEBUIA IMPETIGINOSA, THUJA OCCIDENTALIS, ASTRAGALUS MEMBRANACEUS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), ZINCUM GLUCONICUM, JUNIPERUS VIRGINIANA, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, ORCHITINUM (SUIS), PROSTATE (SUIS), PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, SPONGIA TOSTA, CALCAREA SULPHURICA, LYCOPODIUM CLAVATUM, PHOSPHORUS, BOTULINUM, ESCHERICHIA COLI, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, SALMONELLA TYPHINOSODEBioActive Nutritional, Inc.d3f89e4d-c3a0-4481-bf0e-0413993a8bc52023-08-03WarningsExact identifier
ndc (package): 43857-0523-1
ndc (product): 43857-0523
ndc11 (package): 43857052301
spl id: 7517aa39-3fcc-4b14-836f-29c04c6de480
spl set id: d3f89e4d-c3a0-4481-bf0e-0413993a8bc5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.