FDA.reportPublic FDA data

Helonias Combination

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:50:25

Label at a glance#

ProductHelonias Combination 9227
Active ingredientVIBURNUM OPULUS BARK, APIS MELLIFERA, BLACK COHOSH, LILIUM LANCIFOLIUM WHOLE FLOWERING, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, PULSATILLA MONTANA WHOLE, VESPA CRABRO, CHAMAELIRIUM LUTEUM ROOT, AMMONIUM BROMIDE, GOLD MONOIODIDE, CHLAMYDIA TRACHOMATIS, LACHESIS MUTA VENOM, MERCURIC CHLORIDE, NAJA NAJA VENOM, PALLADIUM
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

Viburnum opulus 2X
Apis mellifica 4X
Cimicifuga racemosa 4X
Lilium tigrinum 4X
Lycopodium clavatum 4X
Melilotus officinalis 4X
Pulsatilla 4X
Vespa crabro 4X
Helonias dioica 6X
Ammonium bromatum 8X
Aurum iodatum 12X
Chlamydia 12X
Lachesis mutus 12X
Mercurius corrosivus 12X
Naja tripudians 12X
Palladium metallicum 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of mild to moderate pain, inflammation, nausea, or occasional headache associated with dysmenorrhea.*

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

Helonias Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9227-12026-01-08C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227
63083-9227-12026-01-08C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227
63083-9227-12024-01-30C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227
63083-9227-12024-01-30C16284748780-11030e365-508b-111a-e063-dadaa90a10e2R227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9227-1Helonias Combination922729.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-922763083-9227-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
APIS MELLIFERA7S82P3R43ZACTIB
BLACK COHOSHK73E24S6X9ACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MELILOTUS OFFICINALIS TOPGM6P02J2DXACTIB
PULSATILLA MONTANA WHOLE24K790T39BACTIB
VESPA CRABROK3ALM8S49HACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
AMMONIUM BROMIDER0JB3224WSACTIB
GOLD MONOIODIDET1UDV7ES1AACTIB
CHLAMYDIA TRACHOMATIST6NI39QU44ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
PALLADIUM5TWQ1V240MACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:15:50

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
Helonias Combination 9227HELONIAS COMBINATIONProfessional Complementary Health Formulas861f6d82-9bd8-4911-a751-9b93ae2210e92026-01-08WarningsExact identifier
ndc (package): 63083-9227-1
ndc (product): 63083-9227
ndc11 (package): 63083922701
spl id: 365bca44-ba7b-4fa8-bc03-b1c2edf3ed7b
spl set id: 861f6d82-9bd8-4911-a751-9b93ae2210e9

Reported adverse events (FAERS/openFDA)#

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