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
ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CARBO ANIMALIS; CHELIDONIUM MAJUS WHOLE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAF
Active strength
3; 3; 12; 12; 3; 12; 6; 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

Additional Listing Data#

Finished product
Yes
Brand name base
Envirostat
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii597E9BI3Z3, 1TH8Q20J0U, O3B55K4YKI, 279O8I0433, 7E889U5RNN, 27YLU75U4W, 11E6VI8VEG, QDL83WN8C2, 269XH13919, 70FD1KFU70, 0T0DQN8786

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

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