FDA.reportPublic FDA data

Umcka Original ColdCare

Product NDC
53499-5270
Requested package NDC
53499-5270-4
11-digit product format
534995270
Labeler code
53499
Product ID
53499-5270_4f6f2f43-9929-40fa-8c0d-9b9a94c14b98
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
LIQUID
Route
ORAL
Labeler
Schwabe North America
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-02-02
Marketing end
0000-00-00
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/30mL
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 packagepackage53499-527053499-5270-4DDiscontinued 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 · 6 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EUMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY HOLDING CO.]2
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY HOLDING CO.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY HOLDING CO.]2
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY HOLDING CO.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-5270-4534995270041 BOTTLE, DROPPER in 1 CARTON (53499-5270-4) > 30 mL in 1 BOTTLE, DROPPER2009-02-020000-00-00NoNoCurrent