D01

Product NDC
63479-0401
11-digit product format
634790401
Labeler code
63479
Product ID
63479-0401_0e76e634-d93f-70ac-e063-6294a90a6ad3
Type
HUMAN OTC DRUG
Nonproprietary name
ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1993-03-15
Substance
SOLIDAGO VIRGAUREA FLOWERING TOP; ALFALFA; GARLIC; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; NICKEL; PASSIFLORA INCARNATA FLOWERING TOP; JUNIPERUS VIRGINIANA TWIG; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; GOLDENSEAL; LACTIC ACID, L-; ASPARAGUS; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK
Active strength
6; 1; 8; 10; 1; 12; 1; 6; 6; 1; 12; 30; 8; 15; 6 [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
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]
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
D01
Brand name suffix
DRAINAGE COMPLEX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]/mL
ALFALFA1 [hp_X]/mL
GARLIC8 [hp_X]/mL
CHELIDONIUM MAJUS10 [hp_X]/mL
GLYCYRRHIZA GLABRA1 [hp_X]/mL
NICKEL12 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]/mL
JUNIPERUS VIRGINIANA TWIG6 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL
AVENA SATIVA FLOWERING TOP1 [hp_X]/mL
GOLDENSEAL12 [hp_X]/mL
LACTIC ACID, L-30 [hp_X]/mL
ASPARAGUS8 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5405K23S50Internal UNII lookup
DJO934BRBDInternal UNII lookup
V1V998DC17Internal UNII lookup
7E889U5RNNInternal UNII lookup
2788Z9758HInternal UNII lookup
7OV03QG267Internal UNII lookup
CLF5YFS11OInternal UNII lookup
532BCG080LInternal UNII lookup
39981FM375Internal UNII lookup
MA9CQJ3F7FInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
F9S9FFU82NInternal UNII lookup
Z1EJP3037ZInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
1TH8Q20J0UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba7020bf-3fc5-4fbf-e053-2995a90a70d7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0401-1D01DRAINAGE COMPLEX30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0401D01 DRAINAGE COMPLEX (ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_ba7020bf-3fc5-4fbf-e053-2995a90a70d7.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
D01 DRAINAGE COMPLEXALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALEApex Energetics Inc.ba7020bf-3fc5-4fbf-e053-2995a90a70d72024-01-08WarningsExact identifier
ndc (product): 63479-0401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0401-16347904010130 mL in 1 BOTTLE, GLASS (63479-0401-1) 30 ml1993-03-150000-00-00NoNoCurrent