FDA.reportPublic FDA data

DEFAETON

Product NDC
59469-133
11-digit product format
594690133
Labeler code
59469
Product ID
59469-133_eac362c3-95fe-4916-b408-014484204823
Type
HUMAN OTC DRUG
Nonproprietary name
Peumus boldus Leaf, Dioscorea villosa Tuber, Strychnos ignatii Seed, Cynara scolymus Whole, Fumaria officinalis Whole, Frangula Alnus Bark, and Rheum officinale Root
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-12-11
Substance
CYNARA SCOLYMUS WHOLE; DIOSCOREA VILLOSA TUBER; FRANGULA ALNUS BARK; FUMARIA OFFICINALIS WHOLE; PEUMUS BOLDUS LEAF; RHEUM OFFICINALE ROOT; STRYCHNOS IGNATII SEED
Active strength
12; 4; 8; 6; 6; 8; 6 [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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEFAETONPEUMUS BOLDUS LEAF, DIOSCOREA VILLOSA TUBER, STRYCHNOS IGNATII SEED, CYNARA SCOLYMUS WHOLE, FUMARIA OFFICINALIS WHOLE, FRANGULA ALNUS BARK, AND RHEUM OFFICINALE ROOTPEKANA Naturheilmittel GmbH7099c648-4de6-4600-9fbc-f9bc600dcf7a2023-01-11WarningsExact identifier
ndc (product): 59469-133

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEUMUS BOLDUS LEAF12 [hp_X]/50mL
DIOSCOREA VILLOSA TUBER4 [hp_X]/50mL
STRYCHNOS IGNATII SEED8 [hp_X]/50mL
CYNARA SCOLYMUS WHOLE6 [hp_X]/50mL
FUMARIA OFFICINALIS WHOLE6 [hp_X]/50mL
FRANGULA ALNUS BARK8 [hp_X]/50mL
RHEUM OFFICINALE ROOT6 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q4EWM09M3OInternal UNII lookup
IWY3IWX2G8Internal UNII lookup
1NM3M2487KInternal UNII lookup
9N3437ZUU0Internal UNII lookup
DM87NN227ZInternal UNII lookup
S2D77IH61RInternal UNII lookup
A47JP5ZG9MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7099c648-4de6-4600-9fbc-f9bc600dcf7aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-133-10DEFAETON1 in 1 BOXSOLUTION/ DROPS16
59469-133-10DEFAETON50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS506
59469-133-40DEFAETON100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1006
59469-133-40DEFAETON1 in 1 BOXSOLUTION/ DROPS16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-133DEFAETON (PEUMUS BOLDUS LEAF, DIOSCOREA VILLOSA TUBER, STRYCHNOS IGNATII SEED, CYNARA SCOLYMUS WHOLE, FUMARIA OFFICINALIS WHOLE, FRANGULA ALNUS BARK, AND RHEUM OFFICINALE ROOT) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]6Current NDC, Legacy NDC, 4 package rows20230113_7099c648-4de6-4600-9fbc-f9bc600dcf7a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-133-10594690133101 BOTTLE, GLASS in 1 BOX (59469-133-10) / 50 mL in 1 BOTTLE, GLASS2008-12-110000-00-00NoNoCurrent
59469-133-40594690133401 BOTTLE, GLASS in 1 BOX (59469-133-40) / 100 mL in 1 BOTTLE, GLASS2017-05-010000-00-00NoNoCurrent