FDA.reportPublic FDA data

Bionica Combination

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2019-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:51

Label at a glance#

ProductBionica Combination 9280
Active ingredientHOLOTHURIA SEA CUCUMBER, ARNICA MONTANA WHOLE, BENZOIC ACID, ECHINACEA ANGUSTIFOLIA WHOLE, MERCURIALIS PERENNIS WHOLE, APIS MELLIFERA, BAPTISIA TINCTORIA WHOLE, BRYONIA ALBA ROOT, COLCHICUM AUTUMNALE BULB, SOLANUM DULCAMARA WHOLE, EUCALYPTUS GLOBULUS LEAF, SOLANUM NIGRUM TOP, EUPATORIUM PERFOLIATUM FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Beche de mer 1X
Arnica montana 3X
Benzoicum acidum 3X
Echinacea angustifolia 3X
Mercurialis perennis 3X
Apis mellifica 4X
Baptisia tinctoria 4X
Bryonia 4X
Colchicum autumnale 4X
Dulcamara 4X
Eucalyptus globulus 4X
Solanum nigrum 4X
Eupatorium perfoliatum 6X
Rhus toxicodendron 6X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches, pains, or swelling in muscles or joints.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

In case of overdose, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

40% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Bionica Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9280-12026-01-09C16284748780-11030e364-fdfc-111a-e063-dadaa90a10e2R280
63083-9280-12024-01-30C16284748780-11030e364-fdfc-111a-e063-dadaa90a10e2R280

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9280BIONICA COMBINATION 9280 (BIONICA COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Legacy NDC20220210_8f839036-e474-41a5-8c29-ed6f5f308411.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-928063083-9280-1

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
HOLOTHURIA SEA CUCUMBER6ZF4R28H4AACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
BENZOIC ACID8SKN0B0MIMACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
MERCURIALIS PERENNIS WHOLEQ35465A1MAACTIB
APIS MELLIFERA7S82P3R43ZACTIB
BAPTISIA TINCTORIA WHOLE5K1UO2888YACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
SOLANUM DULCAMARA WHOLEG72JA9DHK5ACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
SOLANUM NIGRUM TOPO4G5C1G3W5ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ALCOHOL3K9958V90MIACT
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
98ba1d24-39cf-4f33-9694-9002a931ca5b8f839036-e474-41a5-8c29-ed6f5f3084112026-01-08WarningsExact identifier
spl set id: 8f839036-e474-41a5-8c29-ed6f5f308411

Reported adverse events (FAERS/openFDA)#

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