FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-09-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-22 03:01:08

Label at a glance#

ProductStomaplex
Active ingredientMILK THISTLE, GENTIANA LUTEA ROOT, SAMBUCUS NIGRA FLOWERING TOP, SENNA LEAF, SUS SCROFA STOMACH, ARSENIC TRIOXIDE, ATROPINE SULFATE, ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Indications and uses

For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arsenicum Album 12X, Atropinum Sulphuricum 12X, Carbo Vegetabilis 12X, Carduus Marianus 3X, Gentiana Lutea 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Sambucus Nigra 3X, Senna 3X, Stomach 8X.

PURPOSE:

OTC - PURPOSE SECTION

Arsenicum Album - acidity,** Atropinum Sulphuricum - weakness,** Carbo Vegetabilis - gas,** Carduus Marianus – upset stomach,** Gentiana Lutea - cramping,** Lycopodium Clavatum - bloatedness,** Nux Vomica – abdominal pain,** Phosphorus - nausea,** Sambucus Nigra - inflammation,** Senna - laxative,** Stomach – upset stomach reliever**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActiveNutritional

STOMAPLEX

HOMEOPATHIC

1 fl. oz. (30 mL)

STOMAPLEXSTOMAPLEX

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810184340485GTIN-13: 0810184340485
EAN-13: 0810184340485
GTIN-12: 810184340485
UPC-A: 810184340485
GTIN storage (14 digits): 00810184340485		BANI0098 Stomaplex 9-16-26.jpg

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-064443857-0644-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MILK THISTLEU946SH95EEACTIB
GENTIANA LUTEA ROOTS72O3284MSACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
SENNA LEAFAK7JF626KXACTIB
SUS SCROFA STOMACHT0920P9Z9AACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPINE SULFATE03J5ZE7KA5ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-09-26full-release2026-06-01 02:28:05

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
ecfecf55-3d51-494a-ab61-bd35207aaf62b308f76e-5f18-455a-a49f-31c790eeeb892024-09-26WarningsExact identifier
spl set id: b308f76e-5f18-455a-a49f-31c790eeeb89

Reported adverse events (FAERS/openFDA)#

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