HELMIN

Product NDC
59469-058
11-digit product format
594690058
Labeler code
59469
Product ID
59469-058_9ca68189-a423-4c95-8e4e-67b7c14d25f4
Type
HUMAN OTC DRUG
Nonproprietary name
Onion, Artemisia abrotanum Flowering Top, Artemisia cina Pre-Flowering Top, Cupric Oxide, Okoubaka aubrevillei Bark, Schoenocaulon officinale Seed, and Spigelia Anthelmia
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; CUPRIC OXIDE; OKOUBAKA AUBREVILLEI BARK; ONION; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA WHOLE
Active strength
8; 12; 12; 4; 6; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable 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
HELMIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONION6 [hp_X]/50mL
ARTEMISIA ABROTANUM FLOWERING TOP8 [hp_X]/50mL
ARTEMISIA CINA PRE-FLOWERING TOP12 [hp_X]/50mL
CUPRIC OXIDE12 [hp_X]/50mL
OKOUBAKA AUBREVILLEI BARK4 [hp_X]/50mL
SCHOENOCAULON OFFICINALE SEED6 [hp_X]/50mL
SPIGELIA ANTHELMIA WHOLE4 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
492225Q21HInternal UNII lookup
QG07G580U0Internal UNII lookup
28M1820ACTInternal UNII lookup
V1XJQ704R4Internal UNII lookup
MK2074187ZInternal UNII lookup
6NAF1689IOInternal UNII lookup
WYT05213GEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e81ec62-d33a-486e-84a0-35158315a5efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-058-20HELMIN50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS506
59469-058-20HELMIN1 in 1 BOXSOLUTION/ DROPS16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-058HELMIN (ONION, ARTEMISIA ABROTANUM FLOWERING TOP, ARTEMISIA CINA PRE-FLOWERING TOP, CUPRIC OXIDE, OKOUBAKA AUBREVILLEI BARK, SCHOENOCAULON OFFICINALE SEED, AND SPIGELIA ANTHELMIA) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]6Current NDC, Legacy NDC, 2 package rows20221223_6e81ec62-d33a-486e-84a0-35158315a5ef.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
HELMINONION, ARTEMISIA ABROTANUM FLOWERING TOP, ARTEMISIA CINA PRE-FLOWERING TOP, CUPRIC OXIDE, OKOUBAKA AUBREVILLEI BARK, SCHOENOCAULON OFFICINALE SEED, AND SPIGELIA ANTHELMIAPEKANA Naturheilmittel GmbH6e81ec62-d33a-486e-84a0-35158315a5ef2022-12-21WarningsExact identifier
ndc (product): 59469-058

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-058-20594690058201 BOTTLE, GLASS in 1 BOX (59469-058-20) / 50 mL in 1 BOTTLE, GLASS2008-04-120000-00-00NoNoCurrent