FDA.reportPublic FDA data

Gout Drops

Product NDC
63083-2080
11-digit product format
630832080
Labeler code
63083
Product ID
63083-2080_de14e93f-43cf-4282-9aa8-58808df90c38
Type
HUMAN OTC DRUG
Nonproprietary name
Gout Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ARNICA MONTANA WHOLE; BENZOIC ACID; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; FORMICA RUFA; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON TOMENTOSUM LEAFY TWIG; SOLANUM DULCAMARA WHOLE; URTICA URENS WHOLE
Active strength
6; 6; 4; 6; 12; 6; 12; 4; 4; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Mood Stabilizer [EPC], Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gout Drops 2080GOUT DROPSProfessional Complementary Health Formulas30696295-01f6-4a50-a932-76fdc7c0501a2026-01-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Additional Listing Data#

Finished product
Yes
Brand name base
Gout Drops
Brand name suffix
2080
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRYONIA ALBA ROOT6 [hp_X]/59mL
SOLANUM DULCAMARA WHOLE6 [hp_X]/59mL
RHODODENDRON TOMENTOSUM LEAFY TWIG4 [hp_X]/59mL
ARNICA MONTANA WHOLE6 [hp_X]/59mL
BENZOIC ACID12 [hp_X]/59mL
COLCHICUM AUTUMNALE BULB6 [hp_X]/59mL
LITHIUM CARBONATE12 [hp_X]/59mL
URTICA URENS WHOLE4 [hp_X]/59mL
FORMICA RUFA4 [hp_X]/59mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT7J046YI2B, G72JA9DHK5, 877L01IZ0P, O80TY208ZW, 8SKN0B0MIM, 993QHL78E6, 2BMD2GNA4V, IHN2NQ5OF9, 55H0W83JO5, C88X29Y479

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2080GOUT DROPS 2080 (GOUT DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220215_30696295-01f6-4a50-a932-76fdc7c0501a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2080-26308320800259 mL in 1 BOTTLE, DROPPER (63083-2080-2) 59 ml1985-08-150000-00-00NoNoCurrent