E07

Product NDC
63479-0507
11-digit product format
634790507
Labeler code
63479
Product ID
63479-0507_0e892003-98dd-bbc6-e063-6294a90a5233
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, CHININUM ARSENICOSUM, COFFEA CRUDA, COLCHICUM AUTUMNALE, CRATAEGUS OXYACANTHA FRUIT, ECHINACEA PURPUREA, ESCHSCHOLTZIA CALIFORNICA, HUMULUS LUPULUS, IGNATIA AMARA, LYCOPUS VIRGINICUS, NUX VOMICA, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRYCHNINUM PHOSPHORICUM, THYROIDINUM, VISCUM ALBUM FRUITING TOP, YELLOW JASMINE ROOT
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-10-16
Substance
ACONITUM NAPELLUS; AMERICAN GINSENG; ARABICA COFFEE BEAN; COLCHICUM AUTUMNALE BULB; CRATAEGUS LAEVIGATA FRUIT; ECHINACEA PURPUREA; ESCHSCHOLZIA CALIFORNICA; GELSEMIUM SEMPERVIRENS ROOT; HOPS; LYCOPUS VIRGINICUS; PASSIFLORA INCARNATA TOP; QUININE ARSENITE; SCUTELLARIA LATERIFLORA WHOLE; STRYCHNINE PHOSPHATE DIHYDRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; VISCUM ALBUM FRUITING TOP
Active strength
8; 15; 12; 12; 4; 3; 1; 12; 1; 1; 1; 6; 1; 12; 8; 12; 9; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage 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
E07
Brand name suffix
TYPE A BALANCE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STRYCHNOS IGNATII SEED8 [hp_X]/mL
LYCOPUS VIRGINICUS15 [hp_X]/mL
PASSIFLORA INCARNATA TOP12 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE12 [hp_X]/mL
CRATAEGUS LAEVIGATA FRUIT4 [hp_X]/mL
COLCHICUM AUTUMNALE BULB3 [hp_X]/mL
ARABICA COFFEE BEAN1 [hp_X]/mL
QUININE ARSENITE12 [hp_X]/mL
AMERICAN GINSENG1 [hp_X]/mL
ACONITUM NAPELLUS1 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED1 [hp_X]/mL
THYROID, UNSPECIFIED6 [hp_X]/mL
STRYCHNINE PHOSPHATE DIHYDRATE1 [hp_X]/mL
VISCUM ALBUM FRUITING TOP12 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT8 [hp_X]/mL
ECHINACEA PURPUREA12 [hp_X]/mL
ESCHSCHOLZIA CALIFORNICA9 [hp_C]/mL
HOPS3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1NM3M2487KInternal UNII lookup
TWH5125Q6FInternal UNII lookup
CLF5YFS11OInternal UNII lookup
7BP4DH5PDCInternal UNII lookup
D5RZ7MF1YFInternal UNII lookup
993QHL78E6Internal UNII lookup
3SW678MX72Internal UNII lookup
42QO5P0NLMInternal UNII lookup
8W75VCV53QInternal UNII lookup
U0NQ8555JDInternal UNII lookup
269XH13919Internal UNII lookup
0B4FDL9I6PInternal UNII lookup
TD67SYY51DInternal UNII lookup
BK9092J5MPInternal UNII lookup
639KR60Q1QInternal UNII lookup
QI7G114Y98Internal UNII lookup
9315HN272XInternal UNII lookup
01G73H6H83Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06c113f5-63be-f431-e063-6294a90a7d4fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0507-1E07TYPE A BALANCE30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0507E07 TYPE A BALANCE (ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, CHININUM ARSENICOSUM, COFFEA CRUDA, COLCHICUM AUTUMNALE, CRATAEGUS OXYACANTHA FRUIT, ECHINACEA PURPUREA, ESCHSCHOLTZIA CALIFORNICA, HUMULUS LUPULUS, IGNATIA AMARA, LYCOPUS VIRGINICUS, NUX VOMICA, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRYCHNINUM PHOSPHORICUM, THYROIDINUM, VISCUM ALBUM FRUITING TOP, YELLOW JASMINE ROOT) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, 1 package rows20240110_06c113f5-63be-f431-e063-6294a90a7d4f.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
E07 TYPE A BALANCEACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, CHININUM ARSENICOSUM, COFFEA CRUDA, COLCHICUM AUTUMNALE, CRATAEGUS OXYACANTHA FRUIT, ECHINACEA PURPUREA, ESCHSCHOLTZIA CALIFORNICA, HUMULUS LUPULUS, IGNATIA AMARA, LYCOPUS VIRGINICUS, NUX VOMICA, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRYCHNINUM PHOSPHORICUM, THYROIDINUM, VISCUM ALBUM FRUITING TOP, YELLOW JASMINE ROOTApex Energetics Inc.06c113f5-63be-f431-e063-6294a90a7d4f2024-01-09WarningsExact identifier
ndc (product): 63479-0507

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63479-0507-16347905070130 mL in 1 BOTTLE, GLASS (63479-0507-1) 30 ml2023-10-16NoNoCurrent