FDA.reportPublic FDA data

Gout Symptom Formula

Manufacturer
King Bio Inc.
Effective date
2011-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:23

Label at a glance#

ProductGout Symptom Formula
Active ingredientAMMONIUM PHOSPHATE, DIBASIC, ATROPA BELLADONNA, COLCHICUM AUTUMNALE BULB, FORMIC ACID, FRAXINUS EXCELSIOR LEAF, LEDUM PALUSTRE TWIG, SODIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, URTICA URENS
Label structure8 sections

Indications and uses

Uses for temporary relief of pain in the foot, heel, toes and joints including: swelling burning itching tingling tearing pains throbbing cramps shooting pains Reference image gout.jpg

Dosage and administration

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed. Adult Dose: 3 pump sprays Children: (2-12 years) 2 pump sprays Reference image gout.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS

Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, and Urtica Urens.

Reference image gout.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION


Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base. 10X, 30X, and LM1 potencies.

Reference image gout.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

Adult Dose: 3 pump sprays

Children: (2-12 years) 2 pump sprays

Reference image gout.jpg

Purpose

OTC - PURPOSE SECTION

For Temporary relief of pain in the foot, heel, toes and joints including: swelling, burning, itching, tingling, tearing pains, throbbing, cramps, shooting pains.

Reference image gout.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other: Tamper resistant for your protection. Use only if safety seal is intact.

Reference image gout.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

Reference image gout.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for temporary relief of pain in the foot, heel, toes and joints including:

  • swelling
  • burning
  • itching
  • tingling
  • tearing pains
  • throbbing
  • cramps
  • shooting pains
Reference image gout.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of label
Image of label

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

www.kingbio.com

Questions? Call 800.543.3245

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357955502128GTIN-13: 0357955502128
EAN-13: 0357955502128
GTIN-12: 357955502128
UPC-A: 357955502128
GTIN storage (14 digits): 00357955502128		gout.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6021-22020-01-31C16284748780-19d75b9d0-44a4-f424-e053-dadaa90a57ceGout Symptom Formula

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMMONIUM PHOSPHATE, DIBASICACTIVE INGREDIENT10LGE70FSU1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
COLCHICUM AUTUMNALE BULBACTIVE INGREDIENT993QHL78E61
FORMIC ACIDACTIVE INGREDIENT0YIW783RG11
FRAXINUS EXCELSIOR LEAFACTIVE INGREDIENTRC38362Q7M1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P1
SODIUM CARBONATEACTIVE INGREDIENT45P3261C7T1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
AMMONIUM PHOSPHATE, DIBASICACTIVE MOIETY10LGE70FSU1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
COLCHICUM AUTUMNALE BULBACTIVE MOIETY993QHL78E61
FORMIC ACIDACTIVE MOIETY0YIW783RG11
FRAXINUS EXCELSIOR LEAFACTIVE MOIETYRC38362Q7M1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-602157955-6021-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM PHOSPHATE, DIBASIC10LGE70FSUACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
FORMIC ACID0YIW783RG1ACTIB
FRAXINUS EXCELSIOR LEAFRC38362Q7MACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
SODIUM CARBONATE45P3261C7TACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
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
116793df-8ad4-421e-99f3-0f9483053ea52402fb8d-b73b-41b3-9475-7e5927cab6652011-11-18WarningsExact identifier
spl id: 116793df-8ad4-421e-99f3-0f9483053ea5
spl set id: 2402fb8d-b73b-41b3-9475-7e5927cab665

Reported adverse events (FAERS/openFDA)#

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