FDA.reportPublic FDA data

Renatone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:37:01

Label at a glance#

ProductRenatone
Active ingredientBERBERIS VULGARIS ROOT BARK, SOLIDAGO VIRGAUREA FLOWERING TOP, LYTTA VESICATORIA, ARSENIC TRIOXIDE, PROTORTONIA CACTI, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, PACKERA AUREA WHOLE
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 16.63% of Arsenicum Album 12X, Cantharis 12X, Coccus Cacti 12X, Lycopodium Clavatum 12X, Phosphorus 12X, Senecio Aureus 12X; 0.10% of Berberis Vulgaris 3X, Solidago Virgaurea 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve urine that is scanty, dark, and offensive, pain in the back, and sensation as if some urine remained after urinating.**

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

WARNINGS:

WARNINGS SECTION

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.

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

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve urine that is scanty, dark, and offensive, pain in the back, and sensation as if some urine remained after urinating.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

RENATONE

1 fl. oz. (30 ml)

RENATONERENATONE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363113700831GTIN-13: 0363113700831
EAN-13: 0363113700831
GTIN-12: 363113700831
UPC-A: 363113700831
GTIN storage (14 digits): 00363113700831		ENRG0651 Renatone 3-10-22.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0249-12024-10-30C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12024-10-30C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12024-01-30C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12024-01-30C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12022-04-13C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12022-04-13C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12022-01-28C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0249-12022-01-28C16284748780-1d6a99b39-7db9-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0249-1Renatone30 mL in 1 BOTTLE, DROPPERLIQUID306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT1
PACKERA AUREAACTIVE INGREDIENT5WS1632J8W1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
PROTORTONIA CACTIACTIVE INGREDIENTLZB7TFX1LT1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S501
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT1
PACKERA AUREAACTIVE MOIETY5WS1632J8W1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PROTORTONIA CACTIACTIVE MOIETYLZB7TFX1LT1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S501
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-024944911-0249-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
PROTORTONIA CACTILZB7TFX1LTACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
PACKERA AUREA WHOLE5WS1632J8WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-30full-release2026-06-01 02:28:36

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
RenatoneBERBERIS VULGARIS, SOLIDAGO VIRGAUREA, CANTHARIS, ARSENICUM ALBUM, COCCUS CACTI, LYCOPODIUM CLAVATUM, PHOSPHORUS, SENECIO AUREUSEnergique, Inc.a1b88ba5-18e1-480b-8bd8-03bda85a7ef12025-10-06WarningsExact identifier
ndc (package): 44911-0249-1
ndc (product): 44911-0249
ndc11 (package): 44911024901
spl id: 12492c1c-badc-446c-9039-dd7b701f64e0
spl set id: a1b88ba5-18e1-480b-8bd8-03bda85a7ef1

Reported adverse events (FAERS/openFDA)#

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