FDA.reportPublic FDA data

SUPREN

Product NDC
59469-060
11-digit product format
594690060
Labeler code
59469
Product ID
59469-060_5882f99c-53c3-428c-9991-2e409eaaf9d4
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenic Trioxide, Sulfuric Acid, Chamaelirium luteum Root, Goldenseal, Wood Creosote, Lemna minor, Magnesium fluoride, and Silicon Dioxide
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
ARSENIC TRIOXIDE; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; LEMNA MINOR WHOLE; MAGNESIUM FLUORIDE; SILICON DIOXIDE; SULFURIC ACID; WOOD CREOSOTE
Active strength
12; 12; 12; 12; 12; 12; 8; 12 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/100mL
SULFURIC ACID12 [hp_X]/100mL
CHAMAELIRIUM LUTEUM ROOT12 [hp_X]/100mL
GOLDENSEAL12 [hp_X]/100mL
WOOD CREOSOTE12 [hp_X]/100mL
LEMNA MINOR WHOLE12 [hp_X]/100mL
MAGNESIUM FLUORIDE8 [hp_X]/100mL
SILICON DIOXIDE12 [hp_X]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup
O40UQP6WCFInternal UNII lookup
DQV54Y5H3UInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
3JYG22FD73Internal UNII lookup
621HHM46SVInternal UNII lookup
5N014C7IWUInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b34740c-b181-4f05-9858-15b7211a4c67Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-060-10SUPREN100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1005
59469-060-10SUPREN1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-060SUPREN (ARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221223_3b34740c-b181-4f05-9858-15b7211a4c67.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
SUPRENARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDEPEKANA Naturheilmittel GmbH3b34740c-b181-4f05-9858-15b7211a4c672022-12-22WarningsExact identifier
ndc (product): 59469-060

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-060-10594690060101 BOTTLE, GLASS in 1 BOX (59469-060-10) / 100 mL in 1 BOTTLE, GLASS2008-04-120000-00-00NoNoCurrent