Envirostat

Product NDC
44911-0483
11-digit product format
449110483
Labeler code
44911
Product ID
44911-0483_162c13d2-d756-4de5-8bf7-7fb46d5dcbd2
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis Vulgaris, Chelidonium Majus, Lappa Major, Phytolacca Decandra, Calcarea Fluorica, Carbo Animalis, Nux Vomica, Phosphorus, Sepia, Sulphur, Thuja Occidentalis
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-11-29
Substance
BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS WHOLE; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; CALCIUM FLUORIDE; CARBO ANIMALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAF
Active strength
3; 3; 3; 6; 12; 12; 12; 12; 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; [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
2026-12-31
Current FDA listing
Yes

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
Envirostat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
ARCTIUM LAPPA ROOT3 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/mL
CALCIUM FLUORIDE12 [hp_X]/mL
CARBO ANIMALIS12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SULFUR12 [hp_X]/mL
THUJA OCCIDENTALIS LEAF12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1TH8Q20J0UInternal UNII lookup
7E889U5RNNInternal UNII lookup
597E9BI3Z3Internal UNII lookup
11E6VI8VEGInternal UNII lookup
O3B55K4YKIInternal UNII lookup
279O8I0433Internal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
QDL83WN8C2Internal UNII lookup
70FD1KFU70Internal UNII lookup
0T0DQN8786Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92372cc8-bc6b-452e-a3fd-7276b4f1c0d8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0483-12023-10-04C16284748780-1f386c64a-4071-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0483-12023-01-30C16284748780-1f386c64a-4071-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0483-1Envirostat30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0483ENVIROSTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA, PHOSPHORUS, SEPIA, SULPHUR, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20231005_92372cc8-bc6b-452e-a3fd-7276b4f1c0d8.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
EnvirostatBERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, PHYTOLACCA DECANDRA, CALCAREA FLUORICA, CARBO ANIMALIS, NUX VOMICA, PHOSPHORUS, SEPIA, SULPHUR, THUJA OCCIDENTALISEnergique, Inc.92372cc8-bc6b-452e-a3fd-7276b4f1c0d82023-10-04WarningsExact identifier
ndc (product): 44911-0483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0483-14491104830130 mL in 1 BOTTLE, DROPPER (44911-0483-1) 30 ml2018-11-290000-00-00NoNoCurrent