FDA.reportPublic FDA data

Kidney-Tone

Product NDC
64578-0149
11-digit product format
645780149
Labeler code
64578
Product ID
64578-0149_58c9102c-b68a-6394-e063-6394a90a9a3a
Type
HUMAN OTC DRUG
Nonproprietary name
Agrimonia 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.
Dosage form
LIQUID
Route
ORAL
Labeler
Energetix Corporation
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-04-01
Substance
AGRIMONIA 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
Active strength
12; 4; 12; 12; 12; 4; 12; 12; 12; 4; 4; 12; 5; 5; 5 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calcium [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Kidney-Tone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AGRIMONIA EUPATORIA12 [hp_X]/59.1mL
BERBERIS VULGARIS ROOT BARK4 [hp_X]/59.1mL
CALCIUM OXALATE MONOHYDRATE12 [hp_X]/59.1mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/59.1mL
LYTTA VESICATORIA12 [hp_X]/59.1mL
ECHINACEA, UNSPECIFIED4 [hp_X]/59.1mL
EQUISETUM ARVENSE TOP12 [hp_X]/59.1mL
FERROSOFERRIC PHOSPHATE12 [hp_X]/59.1mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/59.1mL
CHONDRODENDRON TOMENTOSUM ROOT4 [hp_X]/59.1mL
PETROSELINUM CRISPUM4 [hp_X]/59.1mL
RUBIA TINCTORUM ROOT12 [hp_X]/59.1mL
SARSAPARILLA5 [hp_X]/59.1mL
SOLIDAGO VIRGAUREA FLOWERING TOP5 [hp_X]/59.1mL
ARCTOSTAPHYLOS UVA-URSI LEAF5 [hp_X]/59.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EBU0U94820Internal UNII lookup
1TH8Q20J0UInternal UNII lookup
4PP86KK527Internal UNII lookup
91D9GV0Z28Internal UNII lookup
3Q034RO3BTInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
1DP6Y6B65ZInternal UNII lookup
91GQH8I5F7Internal UNII lookup
C88X29Y479Internal UNII lookup
395A3P448ZInternal UNII lookup
1WZA4Y92EXInternal UNII lookup
0SVP95L23GInternal UNII lookup
2H1576D5WGInternal UNII lookup
5405K23S50Internal UNII lookup
3M5V3D1X36Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ca2cbee-5251-4e96-b48b-823bc5605c2cAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64578-0149-1Kidney-Tone59.1 mL in 1 BOTTLE, DROPPERLIQUID59.19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64578-0149KIDNEY-TONE (AGRIMONIA 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.) LIQUID [ENERGETIX CORPORATION]9Current NDC, Legacy NDC, 1 package rows20241215_9ca2cbee-5251-4e96-b48b-823bc5605c2c.zip

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 (product): 64578-0149

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64578-0149-16457801490159.1 mL in 1 BOTTLE, DROPPER (64578-0149-1) 59.1 ml2017-04-010000-00-00NoNoCurrent