FDA.reportPublic FDA data

SOMA Prouri

Manufacturer
SOMA Biotechnology Co., Ltd
Effective date
2013-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:21

Label at a glance#

ProductSOMA Prouri
Active ingredientCLOVE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

clove


INACTIVE INGREDIENT SECTION

red ginseng powder, coriolus versicolorr, licorice, aralia continentalis, houttuynia cortata, cnidium officinale, cinnamon bark, houttuynia, mulberry leaf, astragalus membranaceus, gigantic angelica, sweet rush, pepper, bongchul, plueropterus multiflorus, caramel


OTC - PURPOSE SECTION

To help the treatment of prostate, sexual dysfunction, urinary incontinence and muscular dystrophy

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

- Take 2 times a day
- adults 5~7 pills
- seniors:  3~5 pills
- children:  1~3 pills



WARNINGS SECTION

 If you have a cardiac disorder or cerebrovascular disease or you are a long-term medicated patient, gradually increase/reduce the dosage from 1 to 3 pills with a week interval.
- Ask a doctor before you take more than 8 pills.
- Do not exceed 8 pills if you do not know your constitution.



DOSAGE & ADMINISTRATION SECTION

for oral use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package insert
package insert

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOVE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58370-1011-12019-11-27C16284748780-19855d018-ea98-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58370-1011-1SOMA Prouri75 g in 1 BOTTLEPILL751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58370-1011SOMA PROURI (CLOVE) PILL [SOMA BIOTECHNOLOGY CO., LTD]1Legacy NDC, 1 package rows20130507_2a36e43e-2c55-4d26-adfe-2406c77c9652.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOVEACTIVE INGREDIENTK48IKT53211
CLOVEACTIVE MOIETYK48IKT53211
ACORUS GRAMINEUS ROOTINACTIVE INGREDIENTZ60N6Q6E191
ANGELICA SINENSIS ROOTINACTIVE INGREDIENTB66F4574UG1
ARALIA CORDATA ROOTINACTIVE INGREDIENT6KW7950A8P1
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXI1
ASTRAGALUS PROPINQUUS ROOTINACTIVE INGREDIENT922OP8YUPF1
CARAMELINACTIVE INGREDIENTT9D99G2B1R1
CINNAMONINACTIVE INGREDIENT5S29HWU6QB1
CNIDIUM OFFICINALE WHOLEINACTIVE INGREDIENTE9V83DB6BY1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H1
HOUTTUYNIA CORDATA FLOWERING TOPINACTIVE INGREDIENTRH041UUZ221
MORUS AUSTRALIS LEAFINACTIVE INGREDIENTIR0M74L5731
PEPPERSINACTIVE INGREDIENTT5KDM4J2391
POLYGONUM CUSPIDATUM WHOLEINACTIVE INGREDIENT1VDG5Y5HS61
TRAMETES VERSICOLOR FRUITING BODYINACTIVE INGREDIENT4C900477MT1
ZEDOARYINACTIVE INGREDIENT123C43G1281

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58370-101158370-1011-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOVEK48IKT5321ACTIB
ASIAN GINSENGCUQ3A77YXIIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ARALIA CORDATA ROOT6KW7950A8PIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
CNIDIUM OFFICINALE WHOLEE9V83DB6BYIACT
CINNAMON5S29HWU6QBIACT
MORUS AUSTRALIS LEAFIR0M74L573IACT
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFIACT
ANGELICA SINENSIS ROOTB66F4574UGIACT
ACORUS GRAMINEUS ROOTZ60N6Q6E19IACT
PEPPERST5KDM4J239IACT
ZEDOARY123C43G128IACT
POLYGONUM CUSPIDATUM WHOLE1VDG5Y5HS6IACT
TRAMETES VERSICOLOR FRUITING BODY4C900477MTIACT
CARAMELT9D99G2B1RIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 11 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARAMELCARAMELT9D99G2B1RCREAM / TOPICAL0.26 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CINNAMONCINNAMON5S29HWU6QBELIXIR / ORAL10.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / RECTALNAExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLOTION / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
CINNAMONCINNAMON5S29HWU6QBCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARAMELCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates

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
e075a7c8-14e3-4265-8e0f-906f1bde2bcd2a36e43e-2c55-4d26-adfe-2406c77c96522013-05-06WarningsExact identifier
spl id: e075a7c8-14e3-4265-8e0f-906f1bde2bcd
spl set id: 2a36e43e-2c55-4d26-adfe-2406c77c9652

Reported adverse events (FAERS/openFDA)#

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