FDA.reportPublic FDA data

Terrestristat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:29

Label at a glance#

ProductTerrestristat
Active ingredientALFALFA, AVENA SATIVA FLOWERING TOP, FUCUS VESICULOSUS, AMERICAN GINSENG, SODIUM CARBONATE, THYROID, SUS SCROFA PINEAL GLAND, RHODODENDRON AUREUM LEAF, SILICON DIOXIDE, SILVER NITRATE, CADMIUM IODIDE, TRIBASIC CALCIUM PHOSPHATE, COPPER, MERCURIC CHLORIDE, PHOSPHORIC ACID, PHOSPHORUS, STRONTIUM CARBONATE, HOLMIUM, RADIUM BROMIDE, CITHARACANTHUS SPINICRUS, URANYL NITRATE HEXAHYDRATE, ALCOHOL, X-RAY EXPOSED (1000 RAD)
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 4.53% of Aralia Quinquefolia 6X, Argentum Nitricum 12X, Cadmium Iodatum 12X, Calcarea Phosphorica 12X, Cuprum Metallicum 12X, Holmium Metallicum 16X, Mercurius Corrosivus 12X, Natrum Carbonicum 6X, Phosphoricum Acidum 12X, Phosphorus 12X, Pineal Gland (Suis) 8X, Quartz 12X, Radium Bromatum 16X, Rhododendron Chrysanthum 10X, Silicea 12X, Strontium Carbonicum 12X, Tarentula Cubensis 30X, Thyroidinum (Suis) 6X, Uranium Nitricum 30X, X-Ray 30X, 60X, 200X; 0.10% of Agate 12X, Alfalfa 3X, Avena Sativa 3X, Fucus Vesiculosus 3X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of nervousness, anxiety, restlessness, weakness, trembling, numbness, skin eruptions and cracking.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of nervousness, anxiety, restlessness, weakness, trembling, numbness, skin eruptions and cracking.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TERRESTRISTAT

2 fl. oz. (60 ml)

TerrestristatTerrestristat

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product 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
44911-0534-12024-07-03C16284748780-1f386c649-b972-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0534-12023-01-30C16284748780-1f386c649-b972-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0534-1Terrestristat60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0534TERRESTRISTAT (ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAY) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240704_c3d2fd24-6b41-4c85-bd5f-c3306e97080e.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
44911-053444911-0534-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALFALFADJO934BRBDACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
AMERICAN GINSENG8W75VCV53QACTIB
SODIUM CARBONATE45P3261C7TACTIB
THYROID6RV024OAUQACTIB
SUS SCROFA PINEAL GLAND050QZ2EDK7ACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SILVER NITRATE95IT3W8JZEACTIB
CADMIUM IODIDE2F2UPU4KCWACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
COPPER789U1901C5ACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
STRONTIUM CARBONATE41YPU4MMCAACTIB
HOLMIUMW1XX32SQN1ACTIB
RADIUM BROMIDER74O7T8569ACTIB
CITHARACANTHUS SPINICRUS3Y5X6RT823ACTIB
URANYL NITRATE HEXAHYDRATE3V057702FYACTIB
ALCOHOL, X-RAY EXPOSED (1000 RAD)6PRJ93602PACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
ndc (package): 44911-0534-1
ndc (product): 44911-0534
ndc11 (package): 44911053401
spl id: 003c2396-f292-4d62-bf2e-4bff907de9c0
spl set id: c3d2fd24-6b41-4c85-bd5f-c3306e97080e

Reported adverse events (FAERS/openFDA)#

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