FDA.reportPublic FDA data

GUNA-PROSTATE

Manufacturer
Guna spa
Effective date
2026-06-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-13 05:10:06

Label at a glance#

ProductGUNA-PROSTATE
Active ingredientFERRIC PICRATE, CHASTE TREE, BARIUM CARBONATE, CHIMAPHILA UMBELLATA, CLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, DIGITALIS, INTERFERON GAMMA-1B, INTERLEUKIN-10, ALDESLEUKIN, MELATONIN, SUS SCROFA PROSTATE, SAW PALMETTO, SELENIUM, DELPHINIUM STAPHISAGRIA SEED, TRANSFORMING GROWTH FACTOR BETA-1, THUJA OCCIDENTALIS LEAFY TWIG, ZINC
Label structure11 sections

Indications and uses

Temporary relief of symptoms such as: Urinary disconfort, hesitancy, frequency Slow or painful urination

Dosage and administration

Directions: Take 15 minutes before meals Adults: 20 drops in a little water, 2 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

AGNUS CASTUS        6X    INCONTINENCE
BARYTA CARBONICA    12X 30X    PAINFUL URINATION
CHIMAPHILA UMBELLATA    6X    DETOXIFICATION
CLEMATIS ERECTA        3X    ANTIOXIDANT
CONIUM MACULATUM    12X 30X    ANTIOXIDANT
DIGITALIS PURPUREA    12X 30X    RELIEVES URINARY IRRITATION
FERRUM PICRINICUM    12X 30X    SUDDEN URGE TO URINATE
INTERFERON GAMMA    4C    ANTIOXIDANT
INTERLEUKIN 10        4C    PAINFUL URINATION
INTERLEUKIN 2        4C    PAINFUL URINATION
MELATONIN        4C    HORMONAL REGULATION
PROSTATE        200X    PAINFUL URINATION
SABAL SERRULATA        3X    PAINFUL URINATION
SELENIUM METALLICUM    12X 30X    SLOWED START OF URINATION
STAPHYSAGRIA        12X 30X    PAINFUL URINATION
TGF BETA        4C    PAINFUL URINATION
THUJA OCCIDENTALIS    12X 30X    SLOWED START OF URINATION
ZINCUM METALLICUM    3X    SLOWED START OF URINATION

USES

OTC - PURPOSE SECTION

Temporary relief of symptoms such as:

  • Urinary disconfort, hesitancy, frequency
  • Slow or painful urination

WARNINGS

WARNINGS SECTION

  • Stop use and ask doctor if symptoms persist more than 5 days or worsen.
  • If pregnant or breast-feeding ask a health professional before use.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • Contains ethyl alcohol 30%

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions:

Take 15 minutes before meals

Adults: 20 drops in a little water, 2 times per day


QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com, tel. (484) 223-3500

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyl alcohol 30%.

INDICATIONS & USAGE SECTION

  • Take 15 minutes before meals.

INDICATIONS & USAGE SECTION

  • indications and usage section

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USPRO5USPRO

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix5USPRO5USPRO.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
d45267e3-883a-4760-85b5-ebc565c21683Product name120150910
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALDESLEUKINACTIVE INGREDIENTM89N0Q7EQR1
BARIUM CARBONATEACTIVE INGREDIENT6P669D8HQ81
CHASTE TREEACTIVE INGREDIENT433OSF3U8A1
CHIMAPHILA UMBELLATAACTIVE INGREDIENTWCK21A9W9J1
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9F1
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF3711
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV1
DIGITALISACTIVE INGREDIENTF1T8QT9U8B1
FERRIC PICRATEACTIVE INGREDIENTKZM8ZRY36A1
HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED)ACTIVE INGREDIENT9SC4O216V91
INTERFERON GAMMA-1BACTIVE INGREDIENT21K6M2I7AG1
MELATONINACTIVE INGREDIENTJL5DK93RCL1
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QS1
SELENIUMACTIVE INGREDIENTH6241UJ22B1
SUS SCROFA PROSTATEACTIVE INGREDIENTO6UD3347K21
THUJA OCCIDENTALIS TWIGACTIVE INGREDIENT1NT28V93971
TRANSFORMING GROWTH FACTOR BETA-1ACTIVE INGREDIENTT7D25J14LT1
ZINCACTIVE INGREDIENTJ41CSQ7QDS1
ALDESLEUKINACTIVE MOIETYM89N0Q7EQR1
BARIUM CATIONACTIVE MOIETYV645272HLN1
CHASTE TREEACTIVE MOIETY433OSF3U8A1
CHIMAPHILA UMBELLATAACTIVE MOIETYWCK21A9W9J1
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9F1
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF3711
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV1
DIGITALISACTIVE MOIETYF1T8QT9U8B1
FERRIC PICRATEACTIVE MOIETYKZM8ZRY36A1
HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED)ACTIVE MOIETY9SC4O216V91
INTERFERON GAMMA-1BACTIVE MOIETY21K6M2I7AG1
MELATONINACTIVE MOIETYJL5DK93RCL1
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QS1
SELENIUMACTIVE MOIETYH6241UJ22B1
SUS SCROFA PROSTATEACTIVE MOIETYO6UD3347K21
THUJA OCCIDENTALIS TWIGACTIVE MOIETY1NT28V93971
TRANSFORMING GROWTH FACTOR BETA-1ACTIVE MOIETYT7D25J14LT1
ZINCACTIVE MOIETYJ41CSQ7QDS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-34617089-346-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC PICRATEKZM8ZRY36AACTIM
ALCOHOL3K9958V90MIACT
CHASTE TREE433OSF3U8AACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
CHIMAPHILA UMBELLATAWCK21A9W9JACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
DIGITALISF1T8QT9U8BACTIB
INTERFERON GAMMA-1B21K6M2I7AGACTIB
INTERLEUKIN-109SC4O216V9ACTIB
ALDESLEUKINM89N0Q7EQRACTIB
MELATONINJL5DK93RCLACTIB
SUS SCROFA PROSTATEO6UD3347K2ACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SELENIUMH6241UJ22BACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
TRANSFORMING GROWTH FACTOR BETA-1T7D25J14LTACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ZINCJ41CSQ7QDSACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22018-12-21full-release2026-06-01 02:11:13

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 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
GUNA-PROSTATEALDESLEUKIN - BARIUM CARBONATE - CHASTE TREE - CHIMAPHILA UMBELLATA - CLEMATIS VITALBA - CONIUM MACULATUM FLOWERING TOP - DELPHINIUM STAPHISAGRIA SEED - DIGITALIS - FERRIC PICRATE - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MELATONIN - SAW PALMETTO - SELENIUM - SUS SCROFA PROSTATE - THUJA OCCIDENTALIS TWIG - TRANSFORMING GROWTH FACTOR BETA-1 - ZINC -Guna spab99bb9ea-339c-4476-8e3c-e1fcbcfd5cda2026-06-11WarningsExact identifier
ndc (package): 17089-346-18
ndc (product): 17089-346
ndc11 (package): 17089034618
spl id: 53f5c4b3-0eb0-5d70-e063-6394a90aa779
spl set id: b99bb9ea-339c-4476-8e3c-e1fcbcfd5cda

Reported adverse events (FAERS/openFDA)#

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