FDA.reportPublic FDA data

Androtox

Product NDC
43857-0523
Requested package NDC
43857-0523-1
11-digit product format
438570523
Labeler code
43857
Product ID
43857-0523_7517aa39-3fcc-4b14-836f-29c04c6de480
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-08-29
Substance
ASTRAGALUS PROPINQUUS ROOT; BOTULINUM TOXIN TYPE A; CALCIUM SULFATE ANHYDROUS; CENTELLA ASIATICA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; ESCHERICHIA COLI; JUNIPERUS VIRGINIANA TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; PULSATILLA PRATENSIS WHOLE; RHODODENDRON AUREUM LEAF; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAW PALMETTO; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG; ZINC GLUCONATE
Active strength
6; 30; 30; 3; 3; 30; 8; 30; 12; 30; 30; 30; 30; 12; 12; 33; 3; 12; 12; 6; 6; 12; 12; 3; 3; 6 [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_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], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA ANGUSTIFOLIA WHOLE6 [hp_X]/mL
CENTELLA ASIATICA WHOLE30 [hp_X]/mL
SAW PALMETTO30 [hp_X]/mL
TABEBUIA IMPETIGINOSA BARK3 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]/mL
ASTRAGALUS PROPINQUUS ROOT30 [hp_X]/mL
SUS SCROFA ADRENAL GLAND8 [hp_X]/mL
SUS SCROFA LYMPH30 [hp_X]/mL
ZINC GLUCONATE12 [hp_X]/mL
JUNIPERUS VIRGINIANA TWIG30 [hp_X]/mL
MERCURIUS SOLUBILIS30 [hp_X]/mL
SODIUM SULFATE30 [hp_X]/mL
SUS SCROFA TESTICLE30 [hp_X]/mL
SUS SCROFA PROSTATE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
RHODODENDRON AUREUM LEAF33 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]/mL
CALCIUM SULFATE ANHYDROUS12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PHOSPHORUS6 [hp_X]/mL
BOTULINUM TOXIN TYPE A6 [hp_X]/mL
ESCHERICHIA COLI12 [hp_X]/mL
PROTEUS VULGARIS12 [hp_X]/mL
PSEUDOMONAS AERUGINOSA3 [hp_X]/mL
PROTEUS MORGANII3 [hp_X]/mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 26 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB06AV5US8Internal UNII lookup
7M867G6T1UInternal UNII lookup
J7WWH9M8QSInternal UNII lookup
6GLA1946WXInternal UNII lookup
1NT28V9397Internal UNII lookup
922OP8YUPFInternal UNII lookup
398IYQ16YVInternal UNII lookup
33A7VYU29LInternal UNII lookup
U6WSN5SQ1ZInternal UNII lookup
532BCG080LInternal UNII lookup
324Y4038G2Internal UNII lookup
0YPR65R21JInternal UNII lookup
KM02613O28Internal UNII lookup
O6UD3347K2Internal UNII lookup
8E272251DIInternal UNII lookup
IV92NQJ73UInternal UNII lookup
1PIP394IIDInternal UNII lookup
E934B3V59HInternal UNII lookup
C88X29Y479Internal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3f89e4d-c3a0-4481-bf0e-0413993a8bc5Available on FDA.report

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0523-14385705230130 mL in 1 BOTTLE, DROPPER (43857-0523-1) 30 ml2019-08-29NoNoCurrent