FDA.reportPublic FDA data

Edemaforce

Product NDC
43857-0395
11-digit product format
438570395
Labeler code
43857
Product ID
43857-0395_36c231fe-47b6-47e5-8f89-7de6c22b7ccb
Type
HUMAN OTC DRUG
Nonproprietary name
Cactus Grandiflorus, Calendula Officinalis, Dulcamara, Leptandra Virginica, Solidago Virgaurea, Convallaria Majalis, Apis Mellifica, Arnica Montana, Berberis Vulgaris, Bryonia (Alba), Chelidonium Majus, Lycopodium Clavatum, Plumbum Metallicum, Sambucus Nigra
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-05-31
Substance
SELENICEREUS GRANDIFLORUS STEM; CALENDULA OFFICINALIS FLOWERING TOP; SOLANUM DULCAMARA TOP; VERONICASTRUM VIRGINICUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; CONVALLARIA MAJALIS; APIS MELLIFERA; ARNICA MONTANA WHOLE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS WHOLE; LYCOPODIUM CLAVATUM SPORE; LEAD; SAMBUCUS NIGRA FLOWERING TOP
Active strength
3; 3; 3; 3; 3; 4; 12; 12; 12; 12; 12; 12; 12; 12 [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], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [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
Edemaforce
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENICEREUS GRANDIFLORUS STEM3 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
SOLANUM DULCAMARA TOP3 [hp_X]/mL
VERONICASTRUM VIRGINICUM ROOT3 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
CONVALLARIA MAJALIS4 [hp_X]/mL
APIS MELLIFERA12 [hp_X]/mL
ARNICA MONTANA WHOLE12 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK12 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
LEAD12 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7114SV0MYKInternal UNII lookup
18E7415PXQInternal UNII lookup
KPS1B1162NInternal UNII lookup
M2O62YTN42Internal UNII lookup
5405K23S50Internal UNII lookup
QHH4HVF5QEInternal UNII lookup
7S82P3R43ZInternal UNII lookup
O80TY208ZWInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
T7J046YI2BInternal UNII lookup
7E889U5RNNInternal UNII lookup
C88X29Y479Internal UNII lookup
2P299V784PInternal UNII lookup
CT03BSA18UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e7d1909-932a-41a3-bad3-be320bb9ef35Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0395-1Edemaforce30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0395EDEMAFORCE (CACTUS GRANDIFLORUS, CALENDULA OFFICINALIS, DULCAMARA, LEPTANDRA VIRGINICA, SOLIDAGO VIRGAUREA, CONVALLARIA MAJALIS, APIS MELLIFICA, ARNICA MONTANA, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PLUMBUM METALLICUM, SAMBUCUS NIGRA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, Legacy NDC, 1 package rows20160602_5e7d1909-932a-41a3-bad3-be320bb9ef35.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
EdemaforceCACTUS GRANDIFLORUS, CALENDULA OFFICINALIS, DULCAMARA, LEPTANDRA VIRGINICA, SOLIDAGO VIRGAUREA, CONVALLARIA MAJALIS, APIS MELLIFICA, ARNICA MONTANA, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PLUMBUM METALLICUM, SAMBUCUS NIGRABioActive Nutritional, Inc.5e7d1909-932a-41a3-bad3-be320bb9ef352026-08-20WarningsExact identifier
ndc (product): 43857-0395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0395-14385703950130 mL in 1 BOTTLE, DROPPER (43857-0395-1) 30 ml2016-05-310000-00-00NoNoCurrent