FDA.reportPublic FDA data

Thymoplex

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:17

Label at a glance#

ProductThymoplex
Active ingredientHORSERADISH, ECHINACEA ANGUSTIFOLIA WHOLE, MARSDENIA CONDURANGO BARK, GINKGO, PINUS SYLVESTRIS LEAFY TWIG, PROPOLIS WAX, SUS SCROFA SPLEEN, HANDROANTHUS IMPETIGINOSUS WHOLE, BOS TAURUS THYMUS, BEE POLLEN, CALCIUM SULFIDE, SUS SCROFA BONE MARROW, PHOSPHORIC ACID, LACHESIS MUTA VENOM
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

Cochlearia Armoracia 3X, Echinacea (Angustifolia) 3X, Condurango 6X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Propolis 6X, Spleen (suis) 6X, Tabebuia Impetiginosa 6X, Thymus (Bovine) 6X, Bee Pollen 8X, Hepar Sulphuris Calcareum 8X, Medulla Ossis Suis 8X, Phosphoricum Acidum 12X, Lachesis Mutus 15X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of sore throat, fever, persistent cough, and fatigue associated with flu.

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.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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

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 sore throat, fever, persistent cough, and fatigue associated with flu.

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 Homeopathic

THYMOPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

ThymoplexThymoplex

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0564-12024-10-18C16284748780-1f386c64a-30a5-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0564-12023-01-30C16284748780-1f386c64a-30a5-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0564-1Thymoplex30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0564THYMOPLEX (COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), CONDURANGO, GINKGO BILOBA, PINUS SYLVESTRIS, PROPOLIS, SPLEEN (SUIS), TABEBUIA IMPETIGINOSA, THYMUS (BOVINE), BEE POLLEN, HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, LACHESIS MUTUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20241020_1f4a9fda-c53e-4c0c-b624-aa48436c0aea.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-056443857-0564-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
HORSERADISH8DS6G120HJACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB
GINKGO19FUJ2C58TACTIB
PINUS SYLVESTRIS LEAFY TWIGQ1RGP4UB73ACTIB
PROPOLIS WAX6Y8XYV2NOFACTIB
SUS SCROFA SPLEEN92AMN5J79YACTIB
HANDROANTHUS IMPETIGINOSUS WHOLED65QWF3541ACTIB
BOS TAURUS THYMUS8XEJ88V2T8ACTIB
BEE POLLEN3729L8MA2CACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
SUS SCROFA BONE MARROWVP2CN2G7Y8ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
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
ThymoplexCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), CONDURANGO, GINKGO BILOBA, PINUS SYLVESTRIS, PROPOLIS, SPLEEN (SUIS), TABEBUIA IMPETIGINOSA, THYMUS (BOVINE), BEE POLLEN, HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.1f4a9fda-c53e-4c0c-b624-aa48436c0aea2024-10-18WarningsExact identifier
ndc (package): 43857-0564-1
ndc (product): 43857-0564
ndc11 (package): 43857056401
spl id: 23bcbd5c-d5f0-4516-abdc-cecfb762ec6b
spl set id: 1f4a9fda-c53e-4c0c-b624-aa48436c0aea

Reported adverse events (FAERS/openFDA)#

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