FDA.reportPublic FDA data

Thyrotox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2016-08-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:08:07

Label at a glance#

ProductThyrotox
Active ingredientCHONDRUS CRISPUS, FUCUS VESICULOSUS, SUS SCROFA THYROID, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, IODINE, POTASSIUM CARBONATE, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDE
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

Chondrus Crispus 3X, Fucus Vesiculosus 3X, Thyroidinum (Suis) 8X, Belladonna 12X, Calcarea Carbonica 12X, Conium Maculatum 12X, Iodium 12X, Kali Carbonicum 12X, Phosphorus 12X, Pulsatilla 12X, Silicea 12X.

INDICATIONS

OTC - PURPOSE SECTION

For temporary relief of difficulty swallowing, flushed face, glaring eyes, excited mental state, nervous & excitable.

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Ethanol.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of difficulty swallowing, flushed face, glaring eyes, excited mental state, nervous & excitable.

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

THYROTOX

HOMEOPATHIC

1 FL OZ  (30 ml)

ThyrotoxThyrotox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0010-1Thyrotox30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0010THYROTOX (CHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20160811_e229a260-13f3-4136-b325-9a8954f8a327.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNA WHOLEACTIVE INGREDIENTDSV74G1P2J1
CHONDRUS CRISPUSACTIVE INGREDIENTOQS23HUA1X1
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF3711
FUCUS VESICULOSUSACTIVE INGREDIENT535G2ABX9M1
IODINEACTIVE INGREDIENT9679TC07X41
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SUS SCROFA THYROIDACTIVE INGREDIENT6RV024OAUQ1
ATROPA BELLADONNA WHOLEACTIVE MOIETYDSV74G1P2J1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
CHONDRUS CRISPUSACTIVE MOIETYOQS23HUA1X1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF3711
FUCUS VESICULOSUSACTIVE MOIETY535G2ABX9M1
IODINEACTIVE MOIETY9679TC07X41
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SUS SCROFA THYROIDACTIVE MOIETY6RV024OAUQ1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-001043857-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHONDRUS CRISPUSOQS23HUA1XACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
SUS SCROFA THYROID6RV024OAUQACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
IODINE9679TC07X4ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
ndc (package): 43857-0010-1
ndc (product): 43857-0010
ndc11 (package): 43857001001
spl id: 33bc9bbd-68e3-461a-a96d-ce9773d8baf9
spl set id: e229a260-13f3-4136-b325-9a8954f8a327

Reported adverse events (FAERS/openFDA)#

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