Zyvestra

Product NDC
57520-0398
11-digit product format
575200398
Labeler code
57520
Product ID
57520-0398_c3e70690-16e5-4dad-8f29-16b6a6f82e81
Type
HUMAN OTC DRUG
Nonproprietary name
Cocculus indicus, Ferrum metallicum, Gelsemium sempervirens, Phytolacca decandra, Pulsatilla, Silicea,
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-12-03
Marketing end
0000-00-00
Substance
ANAMIRTA COCCULUS SEED; IRON; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE
Active strength
55 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct57520-0398IInactivated by FDA2026-10-12
excluded packagepackage57520-039857520-0398-1IInactivated by FDA2026-10-12

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 · 44 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57520-0398-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57520-0398-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57520-0398-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57520-0398-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57520-0398-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57520-0398-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57520-0398-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57520-0398-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57520-0398-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57520-0398-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57520-0398-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57520-0398-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57520-0398-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57520-0398-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57520-0398-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57520-0398-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57520-0398-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57520-0398-1IInactivated 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 packagepackage57520-0398-1IInactivated 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 packagepackage57520-0398-1IInactivated 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 packagepackage57520-0398-1IInactivated 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 packagepackage57520-0398-1EExcluded 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0398-12020-01-31C16284748780-19d75b9d0-af90-f424-e053-dadaa90a57ceZyvestra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57520-0398-1Zyvestra60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANAMIRTA COCCULUS SEEDACTIVE INGREDIENT810258W28UZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
IRONACTIVE INGREDIENTE1UOL152H7ZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4ZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
ANAMIRTA COCCULUS SEEDACTIVE MOIETY810258W28UZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
IRONACTIVE MOIETYE1UOL152H7ZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4ZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57520-0398ZYVESTRA (COCCULUS INDICUS, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRA, PULSATILLA, SILICEA,) TABLET [APOTHECA COMPANY]1Legacy NDC, 1 package rows20101208_b55d309e-40fc-4b9b-bbcc-361767e5ef0f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57520-0398-15752003980160 in 1 BOTTLEHistorical