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
SAW 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
Active strength
3; 12; 12; 12; 3; 3; 3; 12; 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage44911-0033-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44911-0033-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0033-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0033-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0033-11332a3947898…d4bfe170f9cd…

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
Renastat
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J7WWH9M8QSInternal UNII lookup
3Q034RO3BTInternal UNII lookup
2BMD2GNA4VInternal UNII lookup
53GH7MZT1RInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
1WZA4Y92EXInternal UNII lookup
3M5V3D1X36Internal UNII lookup
395A3P448ZInternal UNII lookup
2H1576D5WGInternal UNII lookup
5405K23S50Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
78d45c36-271e-40e5-a836-a18a8c580dffAvailable on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-10-30DRUG FACTS:
2024-01-30DRUG FACTS:
2021-05-18DRUG FACTS:
2021-01-29DRUG 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

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 (product): 44911-0033

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