Stomaplex

Product NDC
43857-0644
11-digit product format
438570644
Labeler code
43857
Product ID
43857-0644_ecfecf55-3d51-494a-ab61-bd35207aaf62
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Gentiana Lutea, Sambucus Nigra, Senna (Cassia Angustifolia), Stomach (Suis), 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
2024-09-26
Substance
ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPINE SULFATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA STOMACH
Active strength
12; 12; 12; 3; 12; 3; 12; 3; 3; 12; 8 [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], Anticholinergic [EPC], Cell-mediated Immunity [PE], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], 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
Stomaplex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILK THISTLE12 [hp_X]/mL
GENTIANA LUTEA ROOT12 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP12 [hp_X]/mL
SENNA LEAF3 [hp_X]/mL
SUS SCROFA STOMACH12 [hp_X]/mL
ARSENIC TRIOXIDE3 [hp_X]/mL
ATROPINE SULFATE12 [hp_X]/mL
ACTIVATED CHARCOAL3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE3 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU946SH95EE, S72O3284MS, CT03BSA18U, AK7JF626KX, T0920P9Z9A, S7V92P67HO, 03J5ZE7KA5, 2P3VWU3H10, C88X29Y479, 269XH13919, 27YLU75U4W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0644-1Stomaplex30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0644STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (SUIS), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, 1 package rows20240927_b308f76e-5f18-455a-a49f-31c790eeeb89.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0644-14385706440130 mL in 1 BOTTLE, DROPPER (43857-0644-1) 30 ml2024-09-26NoNoHistorical