FDA.reportPublic FDA data

Ledum Palustre

Product NDC
53645-1541
Requested package NDC
53645-1541-2
11-digit product format
536451541
Labeler code
53645
Product ID
53645-1541_f03285f2-2fe8-1769-e053-2a95a90a719b
Type
HUMAN OTC DRUG
Nonproprietary name
Ledum Palustre
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-02-03
Marketing end
0000-00-00
Substance
RHODODENDRON TOMENTOSUM LEAFY TWIG
Active strength
6 [hp_X]/23g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage53645-154153645-1541-2DDiscontinued by firm2026-08-11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1541-22021-01-31C16284748780-1ba0f9c33-3f48-a910-e053-dadaa90a0b85Ledum Palustre 6X
53645-1541-22021-01-29C16284748780-1ba0f9c33-3f48-a910-e053-dadaa90a0b85Ledum Palustre 6X

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1541LEDUM PALUSTRE GLOBULE [TRUE BOTANICA, LLC]5Legacy NDC20230502_6195633c-83b4-228b-e053-2a91aa0aecdf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1541-25364515410223 g in 1 BOTTLE (53645-1541-2) 23 g2014-02-030000-00-00NoNoCurrent