FDA.reportPublic FDA data

Oligo Bio Iodine

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:24:57

Label at a glance#

ProductOligo Bio Iodine
Active ingredientCHELIDONIUM MAJUS WHOLE, IODINE, LYCOPUS VIRGINICUS WHOLE, GINKGO, PINUS SYLVESTRIS LEAFY TWIG, FUCUS VESICULOSUS, SPONGIA OFFICINALIS SKELETON, ROASTED, GERMANIUM SESQUIOXIDE, SUS SCROFA PITUITARY GLAND, SUS SCROFA THYROID, CYSTEINE, MANGANESE GLUCONATE, OXOGLURIC ACID, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FERROUS IODIDE, FUMARIC ACID, POTASSIUM IODIDE, SODIUM DIETHYL OXALACETATE, PULSATILLA VULGARIS WHOLE, SILVER, GOLD, COPPER, EUGENOL, FORMALDEHYDE, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM, NICKEL, PALLADIUM, TIN, TITANIUM, ZINC, RUBELLA VIRUS, MUMPS VIRUS, HUMAN COXSACKIEVIRUS A2, HUMAN COXSACKIEVIRUS A7, HUMAN COXSACKIEVIRUS B1, HUMAN COXSACKIEVIRUS B3, HUMAN COXSACKIEVIRUS B4
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

Chelidonium Majus 3X, Iodium 4X, 6X, 12X, Lycopus Virginicus 4X, 6X, 12X, 30X, 200X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Fucus Vesiculosus 6X, 12X, 30X, Spongia Tosta 7X, Germanium Sesquioxide 8X, Hypophysis Suis 8X, 12X, 100X, 200X, Thyroidinum 8X, 12X, 100X, 200X, Cysteinum 9X, Manganese Gluconate 10X, Alpha-Ketoglutaricum Acidum 12X, Calcarea Carbonica 12X, Ferrum Iodatum 12X, Fumaricum Acidum 12X, Kali Iodatum 12X, Natrum Oxalaceticum 12X, Pulsatilla 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum Metallicum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X, Rubella Nosode 16X,30X, 200X, Parotidinum 30X, 200X, Coxsackie A2 16C, 24C, 60C, 400C, Coxsackie A7 16C, 24C, 60C, 400C, Coxsackie B1 16C, 24C, 60C, 400C, Coxsackie B3 16C, 24C, 60C, 400C, Coxsackie B4 16C, 24C, 60C, 400C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fatigue, muscular weakness, weak pulse, tendency to faint, cold hands & feet, low blood pressure, nervous tremor of limbs & sensitive to cold.

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 a 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 fatigue, muscular weakness, weak pulse, tendency to faint, cold hands & feet, low blood pressure, nervous tremor of limbs & sensitive to cold.

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

OLIGO BIO IODINE

HOMEOPATHIC

2 FL OZ (60 ml)

OLIGO BIO IODINEOLIGO BIO IODINE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0603-12023-12-01C16284748780-1f386c649-d8e2-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0603-12023-01-30C16284748780-1f386c649-d8e2-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0603-1Oligo Bio Iodine60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0603OLIGO BIO IODINE (CHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20231202_2f4f53a9-6294-4014-9898-72023b9506f5.zip

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-060343857-0603-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
IODINE9679TC07X4ACTIB
LYCOPUS VIRGINICUS WHOLETWH5125Q6FACTIB
GINKGO19FUJ2C58TACTIB
PINUS SYLVESTRIS LEAFY TWIGQ1RGP4UB73ACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
SUS SCROFA PITUITARY GLANDL0PFEMQ1DTACTIB
SUS SCROFA THYROID6RV024OAUQACTIB
CYSTEINEK848JZ4886ACTIB
MANGANESE GLUCONATE9YY2F980SVACTIB
OXOGLURIC ACID8ID597Z82XACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
FERROUS IODIDEF5452U54PNACTIB
FUMARIC ACID88XHZ13131ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
SODIUM DIETHYL OXALACETATE6CA025Y4FGACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SILVER3M4G523W1GACTIB
GOLD79Y1949PYOACTIB
COPPER789U1901C5ACTIB
EUGENOL3T8H1794QWACTIB
FORMALDEHYDE1HG84L3525ACTIB
LIDOCAINE98PI200987ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
MOLYBDENUM81AH48963UACTIB
NICKEL7OV03QG267ACTIB
PALLADIUM5TWQ1V240MACTIB
TIN387GMG9FH5ACTIB
TITANIUMD1JT611TNEACTIB
ZINCJ41CSQ7QDSACTIB
RUBELLA VIRUSU751HEX436ACTIB
MUMPS VIRUSYF0S03R447ACTIB
HUMAN COXSACKIEVIRUS A282KK5J435EACTIB
HUMAN COXSACKIEVIRUS A7P3026TK92OACTIB
HUMAN COXSACKIEVIRUS B1ADL68M27WDACTIB
HUMAN COXSACKIEVIRUS B369O1DAO10GACTIB
HUMAN COXSACKIEVIRUS B4FYF75V7FDYACTIB
WATER059QF0KO0RIACT

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
Oligo Bio IodineCHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,BioActive Nutritional, Inc.2f4f53a9-6294-4014-9898-72023b9506f52023-12-01WarningsExact identifier
ndc (package): 43857-0603-1
ndc (product): 43857-0603
ndc11 (package): 43857060301
spl id: b7b1fe9e-9916-45d6-96ae-36ad5e28a1e3
spl set id: 2f4f53a9-6294-4014-9898-72023b9506f5

Reported adverse events (FAERS/openFDA)#

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