FDA.reportPublic FDA data

apo-ENTERIT

Product NDC
59469-158
11-digit product format
594690158
Labeler code
59469
Product ID
59469-158_ea8d652c-1583-4429-9d09-928b215a9275
Type
HUMAN OTC DRUG
Nonproprietary name
Citrullus colocynthis Fruit Pulp, Podophyllum, Veratrum album Root, Artemisia abrotanum Flowering Top, Cynara scolymus Whole, and Potentilla anserina Flowering Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
CITRULLUS COLOCYNTHIS FRUIT PULP; PODOPHYLLUM; VERATRUM ALBUM ROOT; ARTEMISIA ABROTANUM FLOWERING TOP; CYNARA SCOLYMUS WHOLE; POTENTILLA ANSERINA FLOWERING TOP
Active strength
4; 4; 4; 760; 2137; 1092 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL; mg/50mL
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
apo-ENTERIT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]/50mL
PODOPHYLLUM4 [hp_X]/50mL
VERATRUM ALBUM ROOT4 [hp_X]/50mL
ARTEMISIA ABROTANUM FLOWERING TOP760 mg/50mL
CYNARA SCOLYMUS WHOLE2137 mg/50mL
POTENTILLA ANSERINA FLOWERING TOP1092 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23H32AOH17Internal UNII lookup
2S713A4VP3Internal UNII lookup
QNS6W5US1ZInternal UNII lookup
QG07G580U0Internal UNII lookup
9N3437ZUU0Internal UNII lookup
H00Y243SK0Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c2efd18-2f1e-4bb3-99e2-b9752db16626Available 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
59469-158-10apo-ENTERIT1 in 1 BOXSOLUTION/ DROPS15
59469-158-10apo-ENTERIT50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-158APO-ENTERIT (CITRULLUS COLOCYNTHIS FRUIT PULP, PODOPHYLLUM, VERATRUM ALBUM ROOT, ARTEMISIA ABROTANUM FLOWERING TOP, CYNARA SCOLYMUS WHOLE, AND POTENTILLA ANSERINA FLOWERING TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221206_0c2efd18-2f1e-4bb3-99e2-b9752db16626.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
apo-ENTERITCITRULLUS COLOCYNTHIS FRUIT PULP, PODOPHYLLUM, VERATRUM ALBUM ROOT, ARTEMISIA ABROTANUM FLOWERING TOP, CYNARA SCOLYMUS WHOLE, AND POTENTILLA ANSERINA FLOWERING TOPPEKANA Naturheilmittel GmbH0c2efd18-2f1e-4bb3-99e2-b9752db166262022-12-02WarningsExact identifier
ndc (product): 59469-158

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-158-10594690158101 BOTTLE, GLASS in 1 BOX (59469-158-10) / 50 mL in 1 BOTTLE, GLASS2008-04-120000-00-00NoNoCurrent