FDA.reportPublic FDA data

Envirostat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:22:27

Label at a glance#

ProductEnvirostat
Active ingredientBERBERIS 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
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 12.46% of Calcarea Fluorica 12X, Carbo Animalis 12X, Nux Vomica 12X, Phosphorus 12X, Phytolacca Decandra 6X, Sepia 12X, Sulphur 12X, Thuja Occidentalis 12X; 0.10% of Berberis Vulgaris 3X, Chelidonium Majus 3X, Lappa Major 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with exposure to smog, dust, and industrial agents, such as head congestion and general exhaustion.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with exposure to smog, dust, and industrial agents, such as head congestion and general exhaustion.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

ENVIROSTAT

1 fl. oz. (30 ml)

EnvirostatEnvirostat

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-048344911-0483-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CARBO ANIMALIS279O8I0433ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
THUJA OCCIDENTALIS LEAF0T0DQN8786ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 (package): 44911-0483-1
ndc (product): 44911-0483
ndc11 (package): 44911048301
spl id: 162c13d2-d756-4de5-8bf7-7fb46d5dcbd2
spl set id: 92372cc8-bc6b-452e-a3fd-7276b4f1c0d8

Reported adverse events (FAERS/openFDA)#

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