Crataegus 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 17:50:16

Label at a glance#

ProductCrataegus Combination 9220
Active ingredientHAWTHORN LEAF WITH FLOWER, SPIGELIA ANTHELMIA WHOLE, POTASSIUM CARBONATE, ARNICA MONTANA WHOLE, SELENICEREUS GRANDIFLORUS STEM, GELSEMIUM SEMPERVIRENS ROOT, CASTOR FIBER SCENT GLAND SECRETION, NITROGLYCERIN, RANUNCULUS BULBOSUS WHOLE, SULFUR
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

Crataegus 1X
Spigelia anthelmia 2X
Kali carbonicum 3X
Arnica montana 4X
Cactus grandiflorus 4X
Gelsemium sempervirens 4X
Castoreum 6X
Glonoinum 6X
Ranunculus bulbosus 6X
Sulphur 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of occasional insomnia, restlessness, or anxiousness.*

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

Crataegus Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9220-12026-01-09C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220
63083-9220-12026-01-09C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220
63083-9220-12024-01-30C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220
63083-9220-12024-01-30C16284748780-11030e365-1b87-111a-e063-dadaa90a10e2R220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9220-1Crataegus Combination922029.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-922063083-9220-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:15:52

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
Crataegus Combination 9220CRATAEGUS COMBINATIONProfessional Complementary Health Formulasad44d561-9004-43f1-8271-ef52b715fa662026-01-08WarningsExact identifier
ndc (package): 63083-9220-1
ndc (product): 63083-9220
ndc11 (package): 63083922001
spl id: a4cf1cd9-4742-4698-95a6-d7601dda94ea
spl set id: ad44d561-9004-43f1-8271-ef52b715fa66

Reported adverse events (FAERS/openFDA)#

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