Somineze

Product NDC
43857-0379
11-digit product format
438570379
Labeler code
43857
Product ID
43857-0379_40b24ea8-6f5b-4253-ba54-963caaa18a2c
Type
HUMAN OTC DRUG
Nonproprietary name
Humulus Lupulus, Passiflora Incarnata, Valeriana Officinalis, Ambrosia Artemisiaefolia, Arsenicum Album, Coffea Tosta, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-14
Substance
AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIOXIDE; COFFEA ARABICA SEED, ROASTED; HOPS; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; VALERIAN
Active strength
12; 12; 12; 3; 12; 3; 12; 12; 12; 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
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], 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
Somineze
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBROSIA ARTEMISIIFOLIA WHOLE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
COFFEA ARABICA SEED, ROASTED12 [hp_X]/mL
HOPS3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
VALERIAN3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9W34L2CQ9A, S7V92P67HO, 9H58JRT35E, 01G73H6H83, C88X29Y479, CLF5YFS11O, E4GA8884NN, ETJ7Z6XBU4, 269XH13919, JWF5YAW3QW

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMBROSIA ARTEMISIIFOLIAACTIVE INGREDIENT9W34L2CQ9ASOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COFFEA ARABICA SEED, ROASTEDACTIVE INGREDIENT9H58JRT35ESOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
HOPSACTIVE INGREDIENT01G73H6H83SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NNSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
AMBROSIA ARTEMISIIFOLIAACTIVE MOIETY9W34L2CQ9ASOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COFFEA ARABICA SEED, ROASTEDACTIVE MOIETY9H58JRT35ESOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
HOPSACTIVE MOIETY01G73H6H83SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NNSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
VALERIANACTIVE MOIETYJWF5YAW3QWSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0379SOMINEZE (HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20180313_c0f80b84-0dd5-416b-abdf-8a0412e0b40b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0379-14385703790130 mL in 1 BOTTLE, DROPPER (43857-0379-1) 30 ml2015-10-140000-00-00NoNoCurrent