FDA.reportPublic FDA data

Gout Drops

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 17:50:53

Label at a glance#

ProductGout Drops 2080
Active ingredientBRYONIA ALBA ROOT, SOLANUM DULCAMARA WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, ARNICA MONTANA WHOLE, BENZOIC ACID, COLCHICUM AUTUMNALE BULB, LITHIUM CARBONATE, URTICA URENS WHOLE, FORMICA RUFA, LYCOPODIUM CLAVATUM SPORE
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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Bryonia 4X
Dulcamara 4X
Ledum palustre 4X
Arnica montana 6X
Benzoicum acidum 6X
Colchicum autumnale 6X
Lithium carbonicum 6X
Urtica urens 6X
Formica rufa 12X
Lycopodium clavatum 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of pain, inflammation, or stiffness of small 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 for up to 6 weeks. For immediate onset of symptoms, take 10 to 15 drops every 15 minutes up to 3 hours. For less severe symptoms, take 10-15 drops hourly up to 8 hours. 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

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Gout Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2080-22026-01-09C16284748780-11030e365-60e1-111a-e063-dadaa90a10e2C80
63083-2080-22026-01-09C16284748780-11030e365-60e1-111a-e063-dadaa90a10e2C80
63083-2080-22024-01-30C16284748780-11030e365-60e1-111a-e063-dadaa90a10e2C80
63083-2080-22024-01-30C16284748780-11030e365-60e1-111a-e063-dadaa90a10e2C80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2080-2Gout Drops208059 mL in 1 BOTTLE, DROPPERLIQUID592

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
63083-208063083-2080-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BRYONIA ALBA ROOTT7J046YI2BACTIB
SOLANUM DULCAMARA WHOLEG72JA9DHK5ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
BENZOIC ACID8SKN0B0MIMACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
FORMICA RUFA55H0W83JO5ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:16:16

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
Gout Drops 2080GOUT DROPSProfessional Complementary Health Formulas30696295-01f6-4a50-a932-76fdc7c0501a2026-01-08WarningsExact identifier
ndc (package): 63083-2080-2
ndc (product): 63083-2080
ndc11 (package): 63083208002
spl id: de14e93f-43cf-4282-9aa8-58808df90c38
spl set id: 30696295-01f6-4a50-a932-76fdc7c0501a

Reported adverse events (FAERS/openFDA)#

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