apo-STRUM

Product NDC
59469-323
11-digit product format
594690323
Labeler code
59469
Product ID
59469-323_f9f8ce45-cc62-4715-876e-b4d38c2cc32f
Type
HUMAN OTC DRUG
Nonproprietary name
CALCIUM FLUORIDE, Conium maculatum Flowering Top, LOPHOPHYTUM LEANDRII, Hedera helix Flowering Twig, MAGNESIUM CARBONATE, Cytisus scoparius Flowering Top, SELENICEREUS GRANDIFLORUS WHOLE, and GALIUM APARINE
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; CYTISUS SCOPARIUS FLOWERING TOP; GALIUM APARINE WHOLE; HEDERA HELIX FLOWERING TWIG; LOPHOPHYTUM LEANDRII; MAGNESIUM CARBONATE; SELENICEREUS GRANDIFLORUS WHOLE
Active strength
8; 6; 6; 584; 3; 4; 8; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
apo-STRUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM FLUORIDE8 [hp_X]/50mL
CONIUM MACULATUM FLOWERING TOP6 [hp_X]/50mL
LOPHOPHYTUM LEANDRII4 [hp_X]/50mL
HEDERA HELIX FLOWERING TWIG3 [hp_X]/50mL
MAGNESIUM CARBONATE8 [hp_X]/50mL
CYTISUS SCOPARIUS FLOWERING TOP6 [hp_X]/50mL
SELENICEREUS GRANDIFLORUS WHOLE4 [hp_X]/50mL
GALIUM APARINE WHOLE584 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O3B55K4YKIInternal UNII lookup
Q28R5GF371Internal UNII lookup
59150S2EOGInternal UNII lookup
3D10KUA6BMInternal UNII lookup
0E53J927NAInternal UNII lookup
XZC6H8R666Internal UNII lookup
X8H7HS7MRMInternal UNII lookup
Z4B6561488Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b4874fc-bb67-4627-8096-acedaeb81592Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-323-10apo-STRUM50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-323-10apo-STRUM1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-323APO-STRUM (CALCIUM FLUORIDE, CONIUM MACULATUM FLOWERING TOP, LOPHOPHYTUM LEANDRII, HEDERA HELIX FLOWERING TWIG, MAGNESIUM CARBONATE, CYTISUS SCOPARIUS FLOWERING TOP, SELENICEREUS GRANDIFLORUS WHOLE, AND GALIUM APARINE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_9b4874fc-bb67-4627-8096-acedaeb81592.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-STRUMCALCIUM FLUORIDE, CONIUM MACULATUM FLOWERING TOP, LOPHOPHYTUM LEANDRII, HEDERA HELIX FLOWERING TWIG, MAGNESIUM CARBONATE, CYTISUS SCOPARIUS FLOWERING TOP, SELENICEREUS GRANDIFLORUS WHOLE, AND GALIUM APARINEPEKANA Naturheilmittel GmbH9b4874fc-bb67-4627-8096-acedaeb815922023-01-11WarningsExact identifier
ndc (product): 59469-323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-323-10594690323101 BOTTLE, GLASS in 1 BOX (59469-323-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent