Gut Brain Spectrum

Product NDC
44911-0531
Requested package NDC
44911-0531-1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Gut Brain Spectrum

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTEMISIA ABROTANUM FLOWERING TOP6 [hp_X]/mL
AETHUSA CYNAPIUM WHOLE12 [hp_C]/mL
BAPTISIA TINCTORIA ROOT6 [hp_X]/mL
CICUTA VIROSA ROOT6 [hp_X]/mL
COPPER15 [hp_X]/mL
DAPHNE MEZEREUM BARK12 [hp_C]/mL
BUFO BUFO CUTANEOUS GLAND12 [hp_C]/mL
HUMAN MILK12 [hp_X]/mL
SUCROSE12 [hp_X]/mL
SEROTONIN HYDROCHLORIDE12 [hp_X]/mL
ALUMINUM OXIDE15 [hp_C]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_C]/mL
CANDIDA ALBICANS12 [hp_C]/mL
HUMAN BREAST TUMOR CELL30 [hp_X]/mL
HELIUM15 [hp_C]/mL
CANIS LUPUS FAMILIARIS MILK12 [hp_C]/mL
MERCURIUS SOLUBILIS30 [hp_X]/mL
SODIUM CHLORIDE12 [hp_C]/mL
SULFUR30 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_C]/mL
FORMALDEHYDE SOLUTION12 [hp_C]/mL
MEASLES VIRUS12 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QG07G580U0Internal UNII lookup
M6936L953CInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
YEA9P21S8NInternal UNII lookup
789U1901C5Internal UNII lookup
X2N6E405GVInternal UNII lookup
Q59QU6N72QInternal UNII lookup
1XCH439UQRInternal UNII lookup
C151H8M554Internal UNII lookup
GKN429M9VSInternal UNII lookup
LMI26O6933Internal UNII lookup
91D9GV0Z28Internal UNII lookup
4D7G21HDBCInternal UNII lookup
C62OO7VD9KInternal UNII lookup
206GF3GB41Internal UNII lookup
G39P120JQTInternal UNII lookup
324Y4038G2Internal UNII lookup
451W47IQ8XInternal UNII lookup
70FD1KFU70Internal UNII lookup
1NT28V9397Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb1566a4-92d4-4f1a-9211-f0c538a83c27Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
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
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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

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
Gut Brain SpectrumABROTANUM (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, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
ndc (package): 44911-0531-1
ndc (product): 44911-0531
ndc11 (package): 44911053101

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