FDA.reportPublic FDA data

apo-OEDEM

Product NDC
59469-302
11-digit product format
594690302
Labeler code
59469
Product ID
59469-302_317b4b69-0711-42ff-9895-b075cee0cea0
Type
HUMAN OTC DRUG
Nonproprietary name
Horse Chestnut, Apocynum cannabinum Root, Convallaria majalis Flowering Top, Helleborus niger Root, Thuja occidentalis Leafy Twig, Sambucus nigra Flowering Top, Filipendula ulmaria Root, and Corn Silk
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel Gmbh
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
APOCYNUM CANNABINUM ROOT; CONVALLARIA MAJALIS FLOWERING TOP; CORN SILK; FILIPENDULA ULMARIA ROOT; HELLEBORUS NIGER ROOT; HORSE CHESTNUT; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
3; 12; 4; 6; 4; 4; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
apo-OEDEM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HORSE CHESTNUT4 [hp_X]/50mL
APOCYNUM CANNABINUM ROOT3 [hp_X]/50mL
CONVALLARIA MAJALIS FLOWERING TOP12 [hp_X]/50mL
HELLEBORUS NIGER ROOT4 [hp_X]/50mL
THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]/50mL
SAMBUCUS NIGRA FLOWERING TOP4 [hp_X]/50mL
FILIPENDULA ULMARIA ROOT6 [hp_X]/50mL
CORN SILK4 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3C18L6RJAZInternal UNII lookup
2F92409L9ZInternal UNII lookup
4G7VTP9FC4Internal UNII lookup
608DGJ6815Internal UNII lookup
1NT28V9397Internal UNII lookup
CT03BSA18UInternal UNII lookup
997724QNDSInternal UNII lookup
7D3VB244UXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36c831b4-f21a-490e-8cca-9a7773eae91eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-302-10apo-OEDEM50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-302-10apo-OEDEM1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-302APO-OEDEM (HORSE CHESTNUT, APOCYNUM CANNABINUM ROOT, CONVALLARIA MAJALIS FLOWERING TOP, HELLEBORUS NIGER ROOT, THUJA OCCIDENTALIS LEAFY TWIG, SAMBUCUS NIGRA FLOWERING TOP, FILIPENDULA ULMARIA ROOT, AND CORN SILK) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_36c831b4-f21a-490e-8cca-9a7773eae91e.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
apo-OEDEMHORSE CHESTNUT, APOCYNUM CANNABINUM ROOT, CONVALLARIA MAJALIS FLOWERING TOP, HELLEBORUS NIGER ROOT, THUJA OCCIDENTALIS LEAFY TWIG, SAMBUCUS NIGRA FLOWERING TOP, FILIPENDULA ULMARIA ROOT, AND CORN SILKPEKANA Naturheilmittel Gmbh36c831b4-f21a-490e-8cca-9a7773eae91e2023-01-11WarningsExact identifier
ndc (product): 59469-302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-302-10594690302101 BOTTLE, GLASS in 1 BOX (59469-302-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent