FDA.reportPublic FDA data

Envirotox

Product NDC
43857-0625
11-digit product format
438570625
Labeler code
43857
Product ID
43857-0625_f359d4a8-911a-474e-9755-5c504eb32011
Type
HUMAN OTC DRUG
Nonproprietary name
Triticum Aestivum, Berberis Vulgaris, Lappa Major, Rhamnus Purshiana, Senns (Cassia Angustifolia), Phytolacca Decandra, Glycyrrhiza Glabra, Stillingia Sylvatica, Trifolium Pratense, Xanthoxylum Fraxineum, Acetonum Acetone, Sodium Tripolyphosphate, Propylene Glycol, Benzinum, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Belladonna, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Belladonna, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum.
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-11
Substance
ACETONE; AMMONIUM CHLORIDE; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA WHOLE; BENZENE; BERBERIS VULGARIS ROOT BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLENE GLYCOL; SENNA LEAF; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; TURPENTINE OIL; ZANTHOXYLUM AMERICANUM BARK
Active strength
9; 9; 3; 12; 9; 3; 3; 6; 12; 12; 12; 4; 9; 3; 9; 9; 6; 12; 6; 1; 9; 6 [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; [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], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct43857-0625IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-062543857-0625-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRITICUM AESTIVUM WHOLE9 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK9 [hp_X]/mL
ARCTIUM LAPPA ROOT3 [hp_X]/mL
FRANGULA PURSHIANA BARK12 [hp_X]/mL
SENNA LEAF9 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT3 [hp_X]/mL
GLYCYRRHIZA GLABRA3 [hp_X]/mL
STILLINGIA SYLVATICA ROOT6 [hp_X]/mL
TRIFOLIUM PRATENSE FLOWER12 [hp_X]/mL
ZANTHOXYLUM AMERICANUM BARK12 [hp_X]/mL
ACETONE12 [hp_X]/mL
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM4 [hp_X]/mL
PROPYLENE GLYCOL9 [hp_X]/mL
BENZENE3 [hp_X]/mL
AMMONIUM CHLORIDE9 [hp_X]/mL
SODIUM LAURYL SULFATE9 [hp_X]/mL
TURPENTINE OIL6 [hp_X]/mL
ATROPA BELLADONNA WHOLE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
NITRIC ACID1 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED9 [hp_X]/mL
PHOSPHORIC ACID6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3C3Y389JBUInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
597E9BI3Z3Internal UNII lookup
4VBP01X99FInternal UNII lookup
AK7JF626KXInternal UNII lookup
11E6VI8VEGInternal UNII lookup
2788Z9758HInternal UNII lookup
QBR70R4FBKInternal UNII lookup
4JS0838828Internal UNII lookup
A4KL1HMZ7TInternal UNII lookup
1364PS73AFInternal UNII lookup
5HK03SA80JInternal UNII lookup
6DC9Q167V3Internal UNII lookup
J64922108FInternal UNII lookup
01Q9PC255DInternal UNII lookup
368GB5141JInternal UNII lookup
C5H0QJ6V7FInternal UNII lookup
DSV74G1P2JInternal UNII lookup
C88X29Y479Internal UNII lookup
411VRN1TV4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b5cfdba-cf4d-4eb0-8c60-20eac6922663Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0625-12024-03-26C16284748780-11030e365-0cef-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0625-12024-01-30C16284748780-11030e365-0cef-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0625-1Envirotox30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0625ENVIROTOX (TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240328_2b5cfdba-cf4d-4eb0-8c60-20eac6922663.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
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
ndc (product): 43857-0625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0625-14385706250130 mL in 1 BOTTLE, DROPPER (43857-0625-1) 30 ml2022-03-110000-00-00NoNoCurrent