STOMAPLEX

Product NDC
43857-0619
11-digit product format
438570619
Labeler code
43857
Product ID
43857-0619_290e3360-05d6-44e5-a876-a35c05b52cc3
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
2021-11-01
Marketing end
2028-08-21
Substance
ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPINE SULFATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; TRIPE
Active strength
12; 12; 12; 3; 12; 12; 3; 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
STOMAPLEX

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
ATROPINE SULFATE12 [hp_X]/mL
GENTIANA LUTEA ROOT3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/mL
SENNA LEAF3 [hp_X]/mL
SILYBUM MARIANUM SEED3 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TRIPE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, S7V92P67HO, 03J5ZE7KA5, S72O3284MS, C88X29Y479, 27YLU75U4W, CT03BSA18U, AK7JF626KX, U946SH95EE, 269XH13919, C46FS57S0X

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0619-12023-07-21C16284748780-1f386c649-e706-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0619-12023-01-30C16284748780-1f386c649-e706-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0619-1STOMAPLEX30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0619STOMAPLEX (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.]3Current NDC, Legacy NDC, 1 package rows20240913_e1b69e9b-ab47-49f4-bd91-89c935533d67.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0619-14385706190130 mL in 1 BOTTLE, DROPPER (43857-0619-1) 30 ml2021-11-012028-08-21NoNoCurrent