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 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