Gut Brain Spectrum

Product NDC
44911-0531
11-digit product format
449110531
Labeler code
44911
Product ID
44911-0531_392e7f15-8de7-4e76-a684-29ca8bcf9268
Type
HUMAN OTC DRUG
Nonproprietary name
Abrotanum (Artemisia Abrotanum), Aethusa Cynapium, Baptisia Tinctoria, Cicuta Virosa, Cuprum Metallicum, Mezereum, Bufo Rana, Lac Materna Humanum, Saccharum Officinale, Serotonin (Hydrochloride), Alumina, Calcarea Phosphorica, Candida Albicans, Carcinosin, Helium, Lac Caninum, Mercurius solubilis, Natrum Muriaticum, Sulphur, Thuja Occidentalis, Formalinum, Morbillinum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-03-05
Marketing end
2027-11-08
Substance
AETHUSA CYNAPIUM WHOLE; ALUMINUM OXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BUFO BUFO CUTANEOUS GLAND; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS MILK; CICUTA VIROSA ROOT; COPPER; DAPHNE MEZEREUM BARK; FORMALDEHYDE SOLUTION; HELIUM; HUMAN BREAST TUMOR CELL; HUMAN MILK; MEASLES VIRUS; MERCURIUS SOLUBILIS; SEROTONIN HYDROCHLORIDE; SODIUM CHLORIDE; SUCROSE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE
Active strength
6; 12; 6; 6; 15; 12; 12; 12; 12; 12; 15; 12; 12; 30; 15; 12; 30; 12; 30; 12; 12; 12 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fungal Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Fungal Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gut Brain Spectrum

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AETHUSA CYNAPIUM WHOLE6 [hp_X]/mL
ALUMINUM OXIDE12 [hp_C]/mL
ARTEMISIA ABROTANUM FLOWERING TOP6 [hp_X]/mL
BAPTISIA TINCTORIA ROOT6 [hp_X]/mL
BUFO BUFO CUTANEOUS GLAND15 [hp_X]/mL
CANDIDA ALBICANS12 [hp_C]/mL
CANIS LUPUS FAMILIARIS MILK12 [hp_C]/mL
CICUTA VIROSA ROOT12 [hp_X]/mL
COPPER12 [hp_X]/mL
DAPHNE MEZEREUM BARK12 [hp_X]/mL
FORMALDEHYDE SOLUTION15 [hp_C]/mL
HELIUM12 [hp_C]/mL
HUMAN BREAST TUMOR CELL12 [hp_C]/mL
HUMAN MILK30 [hp_X]/mL
MEASLES VIRUS15 [hp_C]/mL
MERCURIUS SOLUBILIS12 [hp_C]/mL
SEROTONIN HYDROCHLORIDE30 [hp_X]/mL
SODIUM CHLORIDE12 [hp_C]/mL
SUCROSE30 [hp_X]/mL
SULFUR12 [hp_C]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_C]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6936L953C, LMI26O6933, QG07G580U0, 5EF0HWI5WU, Q59QU6N72Q, 4D7G21HDBC, G39P120JQT, YEA9P21S8N, 789U1901C5, X2N6E405GV, T0H3L6C7I5, 206GF3GB41, C62OO7VD9K, 1XCH439UQR, HT3R7C012Q, 324Y4038G2, GKN429M9VS, 451W47IQ8X, C151H8M554, 70FD1KFU70

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0531-12024-09-27C16284748780-1f386c64a-4195-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0531-12023-01-30C16284748780-1f386c64a-4195-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0531-1Gut Brain Spectrum30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0531GUT BRAIN SPECTRUM (ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240928_cb1566a4-92d4-4f1a-9211-f0c538a83c27.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0531-14491105310130 mL in 1 BOTTLE, DROPPER (44911-0531-1) 30 ml2020-03-052027-11-08NoNoCurrent