FDA.reportPublic FDA data

Umcka Cough

Product NDC
53499-5864
Requested package NDC
53499-5864-4
11-digit product format
534995864
Labeler code
53499
Product ID
53499-5864_06277bbb-7174-4361-b1e8-280aaedfab6d
Type
HUMAN OTC DRUG
Nonproprietary name
UMCKA COUGH
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; PELARGONIUM SIDOIDES ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN
Active strength
3 [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL
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 packagepackage53499-586453499-5864-4DDiscontinued by firm2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-586453499-5864-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5864UMCKA COUGH ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT (UMCKA COUGH) SYRUP [SCHWABE NORTH AMERICA, INC.]13Legacy NDC20240405_fb2fdf2c-c2f2-4945-a66f-9bd9557ffd42.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-5864-4534995864041 BOTTLE in 1 BOX (53499-5864-4) > 120 mL in 1 BOTTLE1 bottle2012-10-010000-00-00NoNoCurrent