FDA.reportPublic FDA data

PROSCENAT

Product NDC
59469-314
Requested package NDC
59469-314-10
11-digit product format
594690314
Labeler code
59469
Product ID
59469-314_2d2d5f9d-97c8-424f-83e1-d2f7dddee82d
Type
HUMAN OTC DRUG
Nonproprietary name
SULFURIC ACID, Lytta vesicatoria, Conium maculatum Flowering Top, Selenium, Delphinium staphisagria Seed, Nasturtium officinale Whole, and Ononis spinosa Whole
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; NASTURTIUM OFFICINALE WHOLE; ONONIS SPINOSA WHOLE; SELENIUM; SULFURIC ACID
Active strength
4; 6; 4; 1852; 2564; 8; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/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
PROSCENAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFURIC ACID4 [hp_X]/50mL
LYTTA VESICATORIA6 [hp_X]/50mL
CONIUM MACULATUM FLOWERING TOP4 [hp_X]/50mL
SELENIUM1852 mg/50mL
DELPHINIUM STAPHISAGRIA SEED2564 mg/50mL
NASTURTIUM OFFICINALE WHOLE8 [hp_X]/50mL
ONONIS SPINOSA WHOLE6 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O40UQP6WCFInternal UNII lookup
3Q034RO3BTInternal UNII lookup
Q28R5GF371Internal UNII lookup
H6241UJ22BInternal UNII lookup
00543AP1JVInternal UNII lookup
P7LJ54BP7GInternal UNII lookup
RP8496915MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fe525a2-7ff6-4704-ab47-08552eb5ba4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-314-10PROSCENAT1 in 1 BOXSOLUTION/ DROPS12
59469-314-10PROSCENAT50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-314PROSCENAT (SULFURIC ACID, LYTTA VESICATORIA, CONIUM MACULATUM FLOWERING TOP, SELENIUM, DELPHINIUM STAPHISAGRIA SEED, NASTURTIUM OFFICINALE WHOLE, AND ONONIS SPINOSA WHOLE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_1fe525a2-7ff6-4704-ab47-08552eb5ba4a.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
PROSCENATSULFURIC ACID, LYTTA VESICATORIA, CONIUM MACULATUM FLOWERING TOP, SELENIUM, DELPHINIUM STAPHISAGRIA SEED, NASTURTIUM OFFICINALE WHOLE, AND ONONIS SPINOSA WHOLEPEKANA Naturheilmittel GmbH1fe525a2-7ff6-4704-ab47-08552eb5ba4a2023-01-11WarningsExact identifier
ndc (package): 59469-314-10
ndc (product): 59469-314
ndc11 (package): 59469031410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-314-10594690314101 BOTTLE, GLASS in 1 BOX (59469-314-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent