FDA.reportPublic FDA data

apo-PULM

Product NDC
59469-101
11-digit product format
594690101
Labeler code
59469
Product ID
59469-101_4146151a-07b7-4e50-9c91-b34e933c1bee
Type
HUMAN OTC DRUG
Nonproprietary name
Onion, Bryonia Dioica Root, Hedera helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala senega Root, Antimony potassium tartrate, and Pulmonaria officinalis Whole
Dosage form
SYRUP
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-12-11
Substance
ANTIMONY POTASSIUM TARTRATE; BRYONIA DIOICA ROOT; HEDERA HELIX FLOWERING TWIG; HYOSCYAMUS NIGER; ONION; PHOSPHORUS; POLYGALA SENEGA ROOT; PULMONARIA OFFICINALIS WHOLE
Active strength
6; 4; 8; 4; 4; 10; 4; 4 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59469-10159469-101-20DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-PULM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONION4 [hp_X]/125mL
BRYONIA DIOICA ROOT4 [hp_X]/125mL
HEDERA HELIX FLOWERING TWIG8 [hp_X]/125mL
HYOSCYAMUS NIGER4 [hp_X]/125mL
PHOSPHORUS10 [hp_X]/125mL
POLYGALA SENEGA ROOT4 [hp_X]/125mL
ANTIMONY POTASSIUM TARTRATE6 [hp_X]/125mL
PULMONARIA OFFICINALIS WHOLE4 [hp_X]/125mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
492225Q21HInternal UNII lookup
53UB5FH7CXInternal UNII lookup
3D10KUA6BMInternal UNII lookup
4WRK2153H3Internal UNII lookup
27YLU75U4WInternal UNII lookup
M7T6H7D4IFInternal UNII lookup
DL6OZ476V3Internal UNII lookup
483B0A2Y00Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bc9a4d1-2b10-444e-93f4-3836e48d60e0Available 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
59469-101-20apo-PULM1 in 1 BOXSYRUP16
59469-101-20apo-PULM125 mL in 1 BOTTLE, GLASSSYRUP1256
59469-101-50apo-PULM1 in 1 BOXSYRUP16
59469-101-50apo-PULM250 mL in 1 BOTTLE, GLASSSYRUP2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-101APO-PULM (ONION, BRYONIA DIOICA ROOT, HEDERA HELIX FLOWERING TWIG, HYOSCYAMUS NIGER, PHOSPHORUS, POLYGALA SENEGA ROOT, ANTIMONY POTASSIUM TARTRATE, AND PULMONARIA OFFICINALIS WHOLE) SYRUP [PEKANA NATURHEILMITTEL GMBH]6Current NDC, Legacy NDC, 4 package rows20221209_0bc9a4d1-2b10-444e-93f4-3836e48d60e0.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-PULMONION, BRYONIA DIOICA ROOT, HEDERA HELIX FLOWERING TWIG, HYOSCYAMUS NIGER, PHOSPHORUS, POLYGALA SENEGA ROOT, ANTIMONY POTASSIUM TARTRATE, AND PULMONARIA OFFICINALIS WHOLEPEKANA Naturheilmittel GmbH0bc9a4d1-2b10-444e-93f4-3836e48d60e02022-12-05WarningsExact identifier
ndc (product): 59469-101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-101-20594690101201 in 1 BOXHistorical
59469-101-50594690101501 BOTTLE, GLASS in 1 BOX (59469-101-50) / 250 mL in 1 BOTTLE, GLASS2020-02-030000-00-00NoNoCurrent