FDA.reportPublic FDA data

Kidney-Tone

Manufacturer
Energetix Corporation
Effective date
2026-08-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-08-13 01:00:55

Label at a glance#

ProductKidney-Tone
Active ingredientAGRIMONIA EUPATORIA, BERBERIS VULGARIS ROOT BARK, CALCIUM OXALATE MONOHYDRATE, TRIBASIC CALCIUM PHOSPHATE, LYTTA VESICATORIA, ECHINACEA, UNSPECIFIED, EQUISETUM ARVENSE TOP, FERROSOFERRIC PHOSPHATE, LYCOPODIUM CLAVATUM SPORE, CHONDRODENDRON TOMENTOSUM ROOT, PETROSELINUM CRISPUM, RUBIA TINCTORUM ROOT, SARSAPARILLA, SOLIDAGO VIRGAUREA FLOWERING TOP, ARCTOSTAPHYLOS UVA-URSI LEAF
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients59.1 mL contains 5.55% of: Agrimonia eup 12X; Berberis vulg 4X, 6X; Calcarea oxal 12X, 30X; Calcarea phos 12X, 30X; Cantharis 12X; Echinacea 4X; Equisetum arv 12X; Ferrum phos 12X; Lycopodium 12X; Pareira 4X; Petroselinum 4X; Rubia 12X; Sarsaparilla 5X; Solidago 5X; Uva-ursi 5X.

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

INDICATIONS & USAGE SECTION

Uses Temporary relief of frequent urination; lower back pain.

WARNINGS SECTION

Warnings

  • In case of overdose, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast- feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Take 30 drops orally twice daily or as directed by a healthcare professional.
  • Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if neck wrap is broken or missing.
  • Shake well before use.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Cane Alcohol, Vegetable Glycerin, Purified Water.

OTC - QUESTIONS SECTION

Distributed by Energetix Corp.

Dahlonega, GA 30533​

Questions? Comments?

800-990-7085

www.energetix.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

energetix

Kidney-Tone

Homeopathic Remedy

Frequent urination; lower back pain

2 fl oz (59.1 mL) / 15% Cane Alcohol

Kidney-Tone r09-25 03041Kidney-Tone r09-25 03041

OTC - PURPOSE SECTION

Purpose  Temporary relief of frequent urination; lower back pain.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64578-014964578-0149-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
AGRIMONIA EUPATORIAEBU0U94820ACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CALCIUM OXALATE MONOHYDRATE4PP86KK527ACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
LYTTA VESICATORIA3Q034RO3BTACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
CHONDRODENDRON TOMENTOSUM ROOT395A3P448ZACTIB
PETROSELINUM CRISPUM1WZA4Y92EXACTIB
RUBIA TINCTORUM ROOT0SVP95L23GACTIB
SARSAPARILLA2H1576D5WGACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-11-20full-release2026-06-01 02:29:37

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-ToneAGRIMONIA EUPATORIA, BERBERIS VULGARIS, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CANTHARIS, ECHINACEA, EQUISETUM ARVENSE, FERRUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, PAREIRA BRAVA, PETROSELINUM SATIVUM, RUBIA TINCTORUM, SARSAPARILLA, SOLIDAGO VIRGAUREA, UVA-URSI.Energetix Corporation9ca2cbee-5251-4e96-b48b-823bc5605c2c2026-08-11WarningsExact identifier
ndc (package): 64578-0149-1
ndc (product): 64578-0149
ndc11 (package): 64578014901
spl id: 58c9102c-b68a-6394-e063-6394a90a9a3a
spl set id: 9ca2cbee-5251-4e96-b48b-823bc5605c2c

Reported adverse events (FAERS/openFDA)#

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