M12

Product NDC
63479-1312
11-digit product format
634791312
Labeler code
63479
Product ID
63479-1312_0e773c6a-016f-fae5-e063-6294a90af595
Type
HUMAN OTC DRUG
Nonproprietary name
ARGENTUM METALLICUM, ARTEMISIA VULGARIS, CICUTA VIROSA, COBALTUM METALLICUM, COCCULUS INDICUS, CONIUM MACULATUM, GINKGO BILOBA, KALI BROMATUM, LATHYRUS SATIVUS, MERCURIUS SOLUBILIS, NUX VOMICA, PLUMBUM METALLICUM, SALIX ALBA, SCOPOLAMINUM HYDROBROMIDUM, SEQUOIADENDRON GIGANTEUM, SUS SCROFA CEREBRUM
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1993-03-15
Substance
SEQUOIADENDRON GIGANTEUM WHOLE; MERCURIUS SOLUBILIS; LEAD; SALIX ALBA BARK; SCOPOLAMINE HYDROBROMIDE; SUS SCROFA CEREBRUM; CICUTA VIROSA ROOT; SILVER; COBALT; GINKGO; ARTEMISIA VULGARIS ROOT; STRYCHNOS NUX-VOMICA SEED; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; POTASSIUM BROMIDE; LATHYRUS SATIVAS SEED
Active strength
2; 10; 20; 2; 10; 12; 6; 15; 20; 2; 2; 10; 4; 10; 8; 2 [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Anticholinergic [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cholinergic Antagonists [MoA], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
M12
Brand name suffix
BRAIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEQUOIADENDRON GIGANTEUM WHOLE2 [hp_X]/mL
MERCURIUS SOLUBILIS10 [hp_Q]/mL
LEAD20 [hp_X]/mL
SALIX ALBA BARK2 [hp_X]/mL
SCOPOLAMINE HYDROBROMIDE10 [hp_X]/mL
SUS SCROFA CEREBRUM12 [hp_C]/mL
CICUTA VIROSA ROOT6 [hp_X]/mL
SILVER15 [hp_X]/mL
COBALT20 [hp_X]/mL
GINKGO2 [hp_X]/mL
ARTEMISIA VULGARIS ROOT2 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED10 [hp_X]/mL
ANAMIRTA COCCULUS SEED4 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP10 [hp_X]/mL
POTASSIUM BROMIDE8 [hp_X]/mL
LATHYRUS SATIVAS SEED2 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CO90XQD9OInternal UNII lookup
324Y4038G2Internal UNII lookup
2P299V784PInternal UNII lookup
205MXS71H7Internal UNII lookup
451IFR0GXBInternal UNII lookup
4GB5DQR532Internal UNII lookup
YEA9P21S8NInternal UNII lookup
3M4G523W1GInternal UNII lookup
3G0H8C9362Internal UNII lookup
19FUJ2C58TInternal UNII lookup
32MP823R8SInternal UNII lookup
269XH13919Internal UNII lookup
810258W28UInternal UNII lookup
Q28R5GF371Internal UNII lookup
OSD78555ZMInternal UNII lookup
8VP54WOT4IInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba72bba7-177e-4f83-e053-2995a90a86ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1312-1M12BRAIN60 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1312M12 BRAIN (ARGENTUM METALLICUM, ARTEMISIA VULGARIS, CICUTA VIROSA, COBALTUM METALLICUM, COCCULUS INDICUS, CONIUM MACULATUM, GINKGO BILOBA, KALI BROMATUM, LATHYRUS SATIVUS, MERCURIUS SOLUBILIS, NUX VOMICA, PLUMBUM METALLICUM, SALIX ALBA, SCOPOLAMINUM HYDROBROMIDUM, SEQUOIADENDRON GIGANTEUM, SUS SCROFA CEREBRUM) SOLUTION/ DROPS [APEX ENERGETICS INC]2Current NDC, Legacy NDC, 1 package rows20240110_ba72bba7-177e-4f83-e053-2995a90a86ec.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
M12 BRAINARGENTUM METALLICUM, ARTEMISIA VULGARIS, CICUTA VIROSA, COBALTUM METALLICUM, COCCULUS INDICUS, CONIUM MACULATUM, GINKGO BILOBA, KALI BROMATUM, LATHYRUS SATIVUS, MERCURIUS SOLUBILIS, NUX VOMICA, PLUMBUM METALLICUM, SALIX ALBA, SCOPOLAMINUM HYDROBROMIDUM, SEQUOIADENDRON GIGANTEUM, SUS SCROFA CEREBRUMApex Energetics Incba72bba7-177e-4f83-e053-2995a90a86ec2024-01-08WarningsExact identifier
ndc (product): 63479-1312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-1312-16347913120160 mL in 1 BOTTLE, GLASS (63479-1312-1) 60 ml1993-03-150000-00-00NoNoCurrent