FDA.reportPublic FDA data

Umcka ColdCare Sugar Free Grape

Product NDC
53499-5794
11-digit product format
534995794
Labeler code
53499
Product ID
53499-5794_65187b83-264f-4e2f-8207-392e7742e7c4
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-09-01
Marketing end
0000-00-00
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53499-5794DDiscontinued by firm2026-08-17
excluded packagepackage53499-579453499-5794-5DDiscontinued by firm2026-08-17

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 · 2 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 productproduct53499-5794DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53499-579453499-5794-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EUMCKA COLDCARE SUGAR FREE GRAPE (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA COLDCARE SUGAR FREE GRAPE (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUMCKA COLDCARE SUGAR FREE GRAPE (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RUMCKA COLDCARE SUGAR FREE GRAPE (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA COLDCARE SUGAR FREE GRAPE (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5794UMCKA COLDCARE SUGAR FREE GRAPE (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]10Legacy NDC20240627_15e2e9ae-5aab-419f-99f7-08c10447c3da.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-5794-5534995794051 BOTTLE, PLASTIC in 1 CARTON (53499-5794-5) > 120 mL in 1 BOTTLE, PLASTIC2006-09-010000-00-00NoNoCurrent