FDA.reportPublic FDA data

Chamomilla

Product NDC
53645-1321
11-digit product format
536451321
Labeler code
53645
Product ID
53645-1321_ba25ed16-eaa7-6d71-e053-2995a90abff5
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-10-07
Marketing end
0000-00-00
Substance
MATRICARIA RECUTITA
Active strength
7 [hp_X]/23g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53645-1321DDiscontinued by firm2026-10-12
excluded packagepackage53645-132153645-1321-2DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1321-22021-01-31C16284748780-1ba0f9c33-5360-a910-e053-dadaa90a0b85Chamomilla 7x
53645-1321-22021-01-29C16284748780-1ba0f9c33-5360-a910-e053-dadaa90a0b85Chamomilla 7x

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZCHAMOMILLA GLOBULE [TRUE BOTANICA, LLC]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZCHAMOMILLA GLOBULE [TRUE BOTANICA, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHAMOMILLA GLOBULE [TRUE BOTANICA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1321CHAMOMILLA GLOBULE [TRUE BOTANICA, LLC]3Legacy NDC20210131_d716efd9-9f11-4247-967d-bdaa43e426e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1321-25364513210223 g in 1 BOTTLE (53645-1321-2) 23 g2013-10-070000-00-00NoNoCurrent