FDA.reportPublic FDA data

Renastat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:28:36

Label at a glance#

ProductRenastat
Active ingredientSAW PALMETTO, LYTTA VESICATORIA, LITHIUM CARBONATE, MERCURIC CHLORIDE, BERBERIS VULGARIS ROOT BARK, PETROSELINUM CRISPUM WHOLE, ARCTOSTAPHYLOS UVA-URSI LEAF, CHONDRODENDRON TOMENTOSUM ROOT, SMILAX ORNATA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP
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): 16.60% of Cantharis 12X, Lithium Carbonicum 12X, Mercurius Corrosivus 12X, Pareira Brava 12X, Sarsaparilla 12X, Solidago Virgaurea 12X; 0.10% of Berberis Vulgaris 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Uva Ursi 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.**

**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.

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.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.**

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

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

RENASTAT

1 fl. oz. (30 ml)

RenastatRenastat

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0033-12024-10-30C16284748780-1ba0f9c33-291a-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0033-12024-01-30C16284748780-1ba0f9c33-291a-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0033-12021-05-18C16284748780-1ba0f9c33-291a-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0033-12021-01-29C16284748780-1ba0f9c33-291a-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0033-1Renastat30 mL in 1 BOTTLE, DROPPERLIQUID307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0033RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]7Current NDC, Legacy NDC, 1 package rows20241031_78d45c36-271e-40e5-a836-a18a8c580dff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X362
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U2
CHONDRODENDRON TOMENTOSUM ROOTACTIVE INGREDIENT395A3P448Z2
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4V2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT2
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R2
PETROSELINUM CRISPUMACTIVE INGREDIENT1WZA4Y92EX2
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QS2
SMILAX REGELII ROOTACTIVE INGREDIENT2H1576D5WG2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S502
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X362
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U2
CHONDRODENDRON TOMENTOSUM ROOTACTIVE MOIETY395A3P448Z2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER662
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT2
MERCURIC CATIONACTIVE MOIETYED30FJ8Y422
PETROSELINUM CRISPUMACTIVE MOIETY1WZA4Y92EX2
SARSAPARILLAACTIVE MOIETY2H1576D5WG2
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QS2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S502
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-003344911-0033-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAW PALMETTOJ7WWH9M8QSACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
PETROSELINUM CRISPUM WHOLE1WZA4Y92EXACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
CHONDRODENDRON TOMENTOSUM ROOT395A3P448ZACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
RenastatBERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUSEnergique, Inc.78d45c36-271e-40e5-a836-a18a8c580dff2024-10-30WarningsExact identifier
ndc (package): 44911-0033-1
ndc (product): 44911-0033
ndc11 (package): 44911003301
spl id: a3be7ff0-099c-4bed-b83a-80a00725a53c
spl set id: 78d45c36-271e-40e5-a836-a18a8c580dff

Reported adverse events (FAERS/openFDA)#

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