FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-12 01:01:04

Label at a glance#

ProductKidney Tonic I
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, PETROSELINUM CRISPUM WHOLE, SOLIDAGO VIRGAUREA FLOWERING TOP, ARCTOSTAPHYLOS UVA-URSI LEAF, GLUTATHIONE, CHONDRODENDRON TOMENTOSUM ROOT, PORK KIDNEY, LYTTA VESICATORIA, LYCOPODIUM CLAVATUM SPORE
Label structure9 sections

Indications and uses

For temporary relief of pain in the back from urinating, constant urging & frequent urination, kidneys sensitive to pressure, and pain from back extending down the thigh.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.

Dosage and administration

• 10 drops orally, 3 times a day. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Cantharis 12X, Echinacea MT, Glutathione 6X, Kidney 8X, 12X, 30X, 200X, Lycopodium Clavatum 12X, Pareira Brava 8X, Petroselinum Sativum MT, Solidago Virgaurea MT, Uva-Ursi MT.

PURPOSE:

OTC - PURPOSE SECTION

Cantharis – burning or stinging pain,** Echinacea – pain or burning,** Glutathione - detoxification,** Kidney – immune support,** Lycopodium Clavatum – relieves bloated abdomen,** Pareira Brava – frequent urination,** Petroselinum Sativum - diuretic,** Solidago Virgaurea – kidney/bladder pain,** Uva-Ursi – cystitis**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of pain in the back from urinating, constant urging & frequent urination, kidneys sensitive to pressure, and pain from back extending down the thigh.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

KIDNEY TONIC I

HOMEOPATHIC

2 fl. oz. (60 mL)

KIDNEY TONIC IKIDNEY TONIC I

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810184340140GTIN-13: 0810184340140
EAN-13: 0810184340140
GTIN-12: 810184340140
UPC-A: 810184340140
GTIN storage (14 digits): 00810184340140		BANI0026 Kidney Tonic I 8-13-26.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0559-12023-07-21C16284748780-1d6a99b39-f309-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0559-12023-07-21C16284748780-1d6a99b39-f309-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0559-12023-07-21C16284748780-1d6a99b39-f309-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0559-12022-01-28C16284748780-1d6a99b39-f309-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0559-12022-01-28C16284748780-1d6a99b39-f309-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0559-12022-01-28C16284748780-1d6a99b39-f309-a426-e053-dadaa90af4c2DRUG FACTS:

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
43857-055943857-0559-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
PETROSELINUM CRISPUM WHOLE1WZA4Y92EXACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
GLUTATHIONEGAN16C9B8OACTIB
CHONDRODENDRON TOMENTOSUM ROOT395A3P448ZACTIB
PORK KIDNEYX7BCI5P86HACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-08-11daily-update2026-08-13 01:01:00
32025-04-04full-release2026-06-01 02:33:08

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
Kidney Tonic IECHINACEA (ANGUSTIFOLIA), PETROSELINUM SATIVUM, SOLIDAGO VIRGAUREA, UVA-URSI, GLUTATHIONE, PAREIRA BRAVA, KIDNEY (SUIS), CANTHARIS, LYCOPODIUM CLAVATUMBioActive Nutritional, Inc.e906713f-16d4-40bf-b665-e59f77c350642026-09-09WarningsExact identifier
ndc (package): 43857-0559-1
ndc (product): 43857-0559
ndc11 (package): 43857055901
spl id: e93f4034-0e46-43ba-9702-233a0eea060e
spl set id: e906713f-16d4-40bf-b665-e59f77c35064

Reported adverse events (FAERS/openFDA)#

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