FDA.reportPublic FDA data

apo-DOLOR

Product NDC
59469-130
11-digit product format
594690130
Labeler code
59469
Product ID
59469-130_7b291567-96a5-4023-91c2-e9cafc019bc1
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum Napellus, Semecarpus anacardium Fruit, Bryonia Dioica Root, Gelsemium sempervirens Root, Menyanthes trifoliata, Piper methysticum Root, Schoenocaulon officinale Seed, and Spigelia Anthelmia
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-12-11
Substance
ACONITUM NAPELLUS WHOLE; BRYONIA DIOICA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MACROPIPER METHYSTICUM ROOT; MENYANTHES TRIFOLIATA WHOLE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM FRUIT; SPIGELIA ANTHELMIA WHOLE
Active strength
12; 3; 4; 8; 3; 3; 6; 3 [hp_X]/50mL; [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
apo-DOLOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE12 [hp_X]/50mL
SEMECARPUS ANACARDIUM FRUIT6 [hp_X]/50mL
BRYONIA DIOICA ROOT3 [hp_X]/50mL
GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]/50mL
MENYANTHES TRIFOLIATA WHOLE3 [hp_X]/50mL
MACROPIPER METHYSTICUM ROOT8 [hp_X]/50mL
SCHOENOCAULON OFFICINALE SEED3 [hp_X]/50mL
SPIGELIA ANTHELMIA WHOLE3 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
7399B063X9Internal UNII lookup
53UB5FH7CXInternal UNII lookup
639KR60Q1QInternal UNII lookup
7H0QTZ446KInternal UNII lookup
BOW48C81XPInternal UNII lookup
6NAF1689IOInternal UNII lookup
WYT05213GEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
748ac14d-4306-48da-bcd4-c2eb6413457dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-130-10apo-DOLOR1 in 1 BOXSOLUTION/ DROPS15
59469-130-10apo-DOLOR50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-130APO-DOLOR (ACONITUM NAPELLUS, SEMECARPUS ANACARDIUM FRUIT, BRYONIA DIOICA ROOT, GELSEMIUM SEMPERVIRENS ROOT, MENYANTHES TRIFOLIATA, PIPER METHYSTICUM ROOT, SCHOENOCAULON OFFICINALE SEED, AND SPIGELIA ANTHELMIA) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221206_748ac14d-4306-48da-bcd4-c2eb6413457d.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-DOLORACONITUM NAPELLUS, SEMECARPUS ANACARDIUM FRUIT, BRYONIA DIOICA ROOT, GELSEMIUM SEMPERVIRENS ROOT, MENYANTHES TRIFOLIATA, PIPER METHYSTICUM ROOT, SCHOENOCAULON OFFICINALE SEED, AND SPIGELIA ANTHELMIAPEKANA Naturheilmittel GmbH748ac14d-4306-48da-bcd4-c2eb6413457d2022-12-02WarningsExact identifier
ndc (product): 59469-130

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-130-10594690130101 BOTTLE, GLASS in 1 BOX (59469-130-10) / 50 mL in 1 BOTTLE, GLASS2008-12-110000-00-00NoNoCurrent