Somineze

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:36:18

Label at a glance#

ProductSomineze
Active ingredientHOPS, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, AMBROSIA ARTEMISIIFOLIA WHOLE, ARSENIC TRIOXIDE, COFFEA ARABICA SEED, ROASTED, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, SILICON DIOXIDE
Label structure9 sections

Indications and uses

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.** **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

Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphoricum Acidum 12X, Silicea 12X, Valeriana Officinalis 3X.

PURPOSE:

OTC - PURPOSE SECTION

Ambrosia Artemisiaefolia – difficulty sleeping,** Arsenicum Album - fatigue,** Coffea Tosta - sleeplessness,** Humulus Lupulus – nervous exhaustion,** Lycopodium Clavatum - irritability,** Nux Vomica - irritability,** Passiflora Incarnata – restless sleep,** Phosphoricum Acidum – fatigue,** Silicea - fatigue,** Valeriana Officinalis – tossing & turning**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.**

**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

BIOActive Nutritional

SOMINEZE

HOMEOPATHIC

1 fl. oz. (30 mL)

SOMINEZESOMINEZE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184340834GTIN-13: 0210184340834
EAN-13: 0210184340834
GTIN-12: 210184340834
UPC-A: 210184340834
GTIN storage (14 digits): 00210184340834
BANI0290 Somineze 6-9-25.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0379-1Somineze30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMBROSIA ARTEMISIIFOLIAACTIVE INGREDIENT9W34L2CQ9A1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35E1
HOPSACTIVE INGREDIENT01G73H6H831
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
AMBROSIA ARTEMISIIFOLIAACTIVE MOIETY9W34L2CQ9A1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35E1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
HOPSACTIVE MOIETY01G73H6H831
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
VALERIANACTIVE MOIETYJWF5YAW3QW1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-037943857-0379-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
ndc (package): 43857-0379-1
ndc (product): 43857-0379
ndc11 (package): 43857037901
spl id: 40b24ea8-6f5b-4253-ba54-963caaa18a2c
spl set id: c0f80b84-0dd5-416b-abdf-8a0412e0b40b

Reported adverse events (FAERS/openFDA)#

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