Renstat

Product NDC
57520-0644
11-digit product format
575200644
Labeler code
57520
Product ID
57520-0644_cde162fc-74e6-483e-8a93-1ec3f09ff714
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis vulgaris, Uva ursi, Sabal serrulata, Petroselinum sativum, Cantharis, Mercurius corrosivus, Solidago virgaurea, Sarsaparilla, Lithium carbonicum, Pareire brava,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-03-02
Marketing end
2022-09-26
Substance
ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; SARSAPARILLA ROOT; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
3 [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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57520-0644DDiscontinued by firm2026-10-05
excluded packagepackage57520-064457520-0644-1DDiscontinued by firm2026-10-05

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57520-0644-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57520-0644-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57520-0644-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57520-0644-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57520-0644-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57520-0644-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57520-0644-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57520-0644-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57520-0644-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57520-0644-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57520-0644-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57520-0644-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57520-0644-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57520-0644-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57520-0644-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57520-0644-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57520-0644-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0644-12022-04-06C16284748780-19d75b9d0-5d22-f424-e053-dadaa90a57ceRenastat
57520-0644-12020-01-31C16284748780-19d75b9d0-5d22-f424-e053-dadaa90a57ceRenastat

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X36RENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0URENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
CHONDRODENDRON TOMENTOSUM ROOTACTIVE INGREDIENT395A3P448ZRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1RRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
PETROSELINUM CRISPUMACTIVE INGREDIENT1WZA4Y92EXRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
SARSAPARILLA ROOTACTIVE INGREDIENTM5552F7Y3QRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QSRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S50RENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X36RENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0URENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
CHONDRODENDRON TOMENTOSUM ROOTACTIVE MOIETY395A3P448ZRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66RENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
MERCURIC CATIONACTIVE MOIETYED30FJ8Y42RENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
PETROSELINUM CRISPUMACTIVE MOIETY1WZA4Y92EXRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
SARSAPARILLA ROOTACTIVE MOIETYM5552F7Y3QRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QSRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S50RENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RRENSTAT (BERBERIS VULGARIS, UVA URSI, SABAL SERRULATA, PETROSELINUM SATIVUM, CANTHARIS, MERCURIUS CORROSIVUS, SOLIDAGO VIRGAUREA, SARSAPARILLA, LITHIUM CARBONICUM, PAREIRE BRAVA,) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0644-15752006440130 mL in 1 BOTTLE, DROPPER (57520-0644-1) 30 ml2011-03-022022-09-26NoNoCurrent