Envirotox

Product NDC
43857-0528
11-digit product format
438570528
Labeler code
43857
Product ID
43857-0528_3a2b9d94-ae3d-4aaf-8ecf-021675bcd435
Type
HUMAN OTC DRUG
Nonproprietary name
Triticum Aestivum, Berberis Vulgaris, Lappa Major, Rhamnus Cathartica, Rhamnus Purshiana, 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
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-12-23
Marketing end
2025-01-07
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; RHAMNUS CATHARTICA FRUIT; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; TURPENTINE OIL; ZANTHOXYLUM AMERICANUM BARK
Active strength
9 [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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43857-0528DDiscontinued by firm2026-08-17
excluded packagepackage43857-052843857-0528-1DDiscontinued by firm2026-08-17

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43857-0528-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43857-0528-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43857-0528-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43857-0528-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43857-0528-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43857-0528-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43857-0528-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43857-0528-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43857-0528-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43857-0528-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0528-12022-03-14C16284748780-1ba0f9c33-2198-a910-e053-dadaa90a0b85Drug Facts:
43857-0528-12021-01-29C16284748780-1ba0f9c33-2198-a910-e053-dadaa90a0b85Drug Facts:

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0528-14385705280130 mL in 1 BOTTLE, DROPPER (43857-0528-1) 30 ml2019-12-232025-01-07NoNoCurrent