Envirostat

Product NDC
57520-0480
Requested package NDC
57520-0480-1
11-digit product format
575200480
Labeler code
57520
Product ID
57520-0480_174b0791-8837-4d0e-982c-7d8d3874b309
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis vulgaris, Chelidonium majus, Lappa major, Phytolacca Decandra, Calcarea fluorica, Carbo animalis, Nux vomica,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-06-04
Marketing end
2022-09-22
Substance
ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CARBO ANIMALIS; CHELIDONIUM MAJUS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG
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; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57520-048057520-0480-1DDiscontinued 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 · 18 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded 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
57520-0480-12022-04-19C16284748780-19d75b9d0-0547-f424-e053-dadaa90a57ceEnvirostat
57520-0480-12020-01-31C16284748780-19d75b9d0-0547-f424-e053-dadaa90a57ceEnvirostat

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARCTIUM LAPPA ROOTACTIVE INGREDIENT597E9BI3Z3ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0UENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKIENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
CARBO ANIMALISACTIVE INGREDIENT279O8I0433ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNNENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
SULFURACTIVE INGREDIENT70FD1KFU70ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V9397ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
ARCTIUM LAPPA ROOTACTIVE MOIETY597E9BI3Z3ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0UENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
CALCIUM FLUORIDEACTIVE MOIETYO3B55K4YKIENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
CARBO ANIMALISACTIVE MOIETY279O8I0433ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNNENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
SULFURACTIVE MOIETY70FD1KFU70ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V9397ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA,) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0480-15752004800130 mL in 1 BOTTLE, DROPPER (57520-0480-1) 30 ml2010-06-042022-09-22NoNoCurrent