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
ACONITUM NAPELLUS8 [hp_X]/mL
AMERICAN GINSENG15 [hp_X]/mL
ARABICA COFFEE BEAN12 [hp_X]/mL
COLCHICUM AUTUMNALE BULB12 [hp_X]/mL
CRATAEGUS LAEVIGATA FRUIT4 [hp_X]/mL
ECHINACEA PURPUREA3 [hp_X]/mL
ESCHSCHOLZIA CALIFORNICA1 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/mL
HOPS1 [hp_X]/mL
LYCOPUS VIRGINICUS1 [hp_X]/mL
PASSIFLORA INCARNATA TOP1 [hp_X]/mL
QUININE ARSENITE6 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE1 [hp_X]/mL
STRYCHNINE PHOSPHATE DIHYDRATE12 [hp_X]/mL
STRYCHNOS IGNATII SEED8 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
THYROID, UNSPECIFIED9 [hp_C]/mL
VISCUM ALBUM FRUITING TOP3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 8W75VCV53Q, 3SW678MX72, 993QHL78E6, D5RZ7MF1YF, QI7G114Y98, 9315HN272X, 639KR60Q1Q, 01G73H6H83, TWH5125Q6F, CLF5YFS11O, 42QO5P0NLM, 7BP4DH5PDC, TD67SYY51D, 1NM3M2487K, 269XH13919, 0B4FDL9I6P, BK9092J5MP

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

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 ml2023-10-16NoNoHistorical