FDA.reportPublic FDA data

Stomaplex

Product NDC
43857-0090
11-digit product format
438570090
Labeler code
43857
Product ID
43857-0090_d83ecc37-859d-449c-9220-ba4921f9adbc
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Gentiana Lutea, Sambucus Nigra, Senna (Cassia Angustifolia), Stomach (Bovine), Arsenicum Album, Atropinum Sulphuricum, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-02-19
Marketing end
2026-02-19
Substance
SILYBUM MARIANUM SEED; GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; TRIPE; ARSENIC TRIOXIDE; ATROPINE SULFATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS
Active strength
3 [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
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 productproduct43857-0090DDiscontinued by firm2026-10-05
excluded packagepackage43857-009043857-0090-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H10STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GENTIANA LUTEA ROOTACTIVE INGREDIENTS72O3284MSSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18USTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SENNA LEAFACTIVE INGREDIENTAK7JF626KXSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EESTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
TRIPEACTIVE INGREDIENTC46FS57S0XSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H10STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ATROPINEACTIVE MOIETY7C0697DR9ISTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GENTIANA LUTEA ROOTACTIVE MOIETYS72O3284MSSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHOSPHORUSACTIVE MOIETY27YLU75U4WSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18USTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SENNA LEAFACTIVE MOIETYAK7JF626KXSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EESTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
TRIPEACTIVE MOIETYC46FS57S0XSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSTOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA, STOMACH, ARSENICUM ALBUM, ATROPINUM SULPHURICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0090STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Legacy NDC20211103_aad682e9-fa0e-4d28-a683-ef4a416c9a2c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0090-14385700900130 mL in 1 BOTTLE, DROPPER (43857-0090-1) 30 ml2016-08-240000-00-00NoNoCurrent