FDA.reportPublic FDA data

Renastat

Product NDC
44911-0033
11-digit product format
449110033
Labeler code
44911
Product ID
44911-0033_a3be7ff0-099c-4bed-b83a-80a00725a53c
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis Vulgaris, Petroselinum Sativum, Sabal Serrulata, Uva Ursi, CAntharis, Lithium Carbonicum, Mercurius Corrosivus
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-10-04
Substance
ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM WHOLE; SAW PALMETTO; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
3; 3; 12; 12; 12; 12; 3; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Renastat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]/mL
LITHIUM CARBONATE12 [hp_X]/mL
LYTTA VESICATORIA12 [hp_X]/mL
MERCURIC CHLORIDE12 [hp_X]/mL
PETROSELINUM CRISPUM WHOLE3 [hp_X]/mL
SAW PALMETTO3 [hp_X]/mL
SMILAX ORNATA ROOT12 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M5V3D1X36, 1TH8Q20J0U, 395A3P448Z, 2BMD2GNA4V, 3Q034RO3BT, 53GH7MZT1R, 1WZA4Y92EX, J7WWH9M8QS, 2H1576D5WG, 5405K23S50

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X36RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0URENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
CHONDRODENDRON TOMENTOSUM ROOTACTIVE INGREDIENT395A3P448ZRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1RRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
PETROSELINUM CRISPUMACTIVE INGREDIENT1WZA4Y92EXRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QSRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
SMILAX REGELII ROOTACTIVE INGREDIENT2H1576D5WGRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S50RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X36RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0URENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
CHONDRODENDRON TOMENTOSUM ROOTACTIVE MOIETY395A3P448ZRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
MERCURIC CATIONACTIVE MOIETYED30FJ8Y42RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
PETROSELINUM CRISPUMACTIVE MOIETY1WZA4Y92EXRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
SARSAPARILLAACTIVE MOIETY2H1576D5WGRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QSRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S50RENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RRENASTAT (BERBERIS VULGARIS, PETROSELINUM SATIVUM, SABAL SERRULATA, UVA URSI, CANTHARIS, LITHIUM CARBONICUM, MERCURIUS CORROSIVUS) LIQUID [ENERGIQUE, INC.]2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0033-14491100330130 mL in 1 BOTTLE, DROPPER (44911-0033-1) 30 ml2012-10-040000-00-00NoNoCurrent