FDA.reportPublic FDA data

Umcka FastActives Cherry

Product NDC
53499-1166
Requested package NDC
53499-1166-0
11-digit product format
534991166
Labeler code
53499
Product ID
53499-1166_00d8c9f6-9d22-4f5c-914f-cd33b3470a8b
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
POWDER
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-07-03
Marketing end
0000-00-00
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/700mg
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 packagepackage53499-116653499-1166-0DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1166-0Umcka FastActives Cherry700 mg in 1 PACKETPOWDER7008
53499-1166-0Umcka FastActives Cherry10 in 1 CARTONPOWDER108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-1166-0EA - Each53499-1166fa8f7951-d5d5-46fa-98dd-d665649a6cb312025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1166UMCKA FASTACTIVES CHERRY (PELARGONIUM SIDOIDES) POWDER [SCHWABE NORTH AMERICA, INC.]8Legacy NDC, 2 package rows20241031_2b3aa577-60b0-4855-ad94-312a6ca0677c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-1166-05349911660010 PACKET in 1 CARTON (53499-1166-0) > 700 mg in 1 PACKET10 packet2018-07-030000-00-00NoNoCurrent