FDA.reportPublic FDA data

PROALLER

Product NDC
59469-116
11-digit product format
594690116
Labeler code
59469
Product ID
59469-116_78ed18a7-da36-4ead-be28-92693f46c272
Type
HUMAN OTC DRUG
Nonproprietary name
Ailanthus altissima Whole, Okoubaka aubrevillei Bark, Euphrasia Stricta, Gratiola officinalis, Juglans regia Whole, Smilax Regelii Root, and Taraxacum officinale Whole
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-12-11
Substance
AILANTHUS ALTISSIMA WHOLE; EUPHRASIA STRICTA; GRATIOLA OFFICINALIS WHOLE; JUGLANS REGIA WHOLE; OKOUBAKA AUBREVILLEI BARK; SMILAX ORNATA ROOT; TARAXACUM OFFICINALE WHOLE
Active strength
4; 3; 4; 6; 3; 8; 12 [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
PROALLER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AILANTHUS ALTISSIMA WHOLE4 [hp_X]/50mL
OKOUBAKA AUBREVILLEI BARK3 [hp_X]/50mL
EUPHRASIA STRICTA4 [hp_X]/50mL
GRATIOLA OFFICINALIS WHOLE6 [hp_X]/50mL
JUGLANS REGIA WHOLE3 [hp_X]/50mL
SMILAX ORNATA ROOT8 [hp_X]/50mL
TARAXACUM OFFICINALE WHOLE12 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5G78C6GB5EInternal UNII lookup
MK2074187ZInternal UNII lookup
C9642I91WLInternal UNII lookup
BDD9991A36Internal UNII lookup
87EJ76IO83Internal UNII lookup
2H1576D5WGInternal UNII lookup
7C42E2D7B0Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
101ff372-e618-4c06-bad1-e2bfbc9e4349Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-116-10PROALLER1 in 1 BOXSOLUTION/ DROPS15
59469-116-10PROALLER50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-116PROALLER (AILANTHUS ALTISSIMA WHOLE, OKOUBAKA AUBREVILLEI BARK, EUPHRASIA STRICTA, GRATIOLA OFFICINALIS, JUGLANS REGIA WHOLE, SMILAX REGELII ROOT, AND TARAXACUM OFFICINALE WHOLE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL]5Current NDC, Legacy NDC, 2 package rows20221221_101ff372-e618-4c06-bad1-e2bfbc9e4349.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
PROALLERAILANTHUS ALTISSIMA WHOLE, OKOUBAKA AUBREVILLEI BARK, EUPHRASIA STRICTA, GRATIOLA OFFICINALIS, JUGLANS REGIA WHOLE, SMILAX REGELII ROOT, AND TARAXACUM OFFICINALE WHOLEPEKANA Naturheilmittel101ff372-e618-4c06-bad1-e2bfbc9e43492022-12-19WarningsExact identifier
ndc (product): 59469-116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-116-10594690116101 BOTTLE, GLASS in 1 BOX (59469-116-10) / 50 mL in 1 BOTTLE, GLASS2008-12-110000-00-00NoNoCurrent