FDA.reportPublic FDA data

Umcka ColdCare Alcohol Free Cherry

Product NDC
53499-5273
Requested package NDC
53499-5273-9
11-digit product format
534995273
Labeler code
53499
Product ID
53499-5273_a3ae9d86-443b-484f-9567-35fe39620169
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-01-01
Marketing end
0000-00-00
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/240mL
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 packagepackage53499-527353499-5273-9DDiscontinued 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 · 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 packagepackage53499-527353499-5273-9DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
ARONIA MELANOCARPA FRUIT JUICEINACTIVE INGREDIENTD2EVP827PJUMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPUMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVUMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CUMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5273UMCKA COLDCARE ALCOHOL FREE CHERRY (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]13Legacy NDC20231003_cb3b6b64-fbac-4a91-b2e2-7b223d51f0ff.zip
53499-5273UMCKA COLDCARE STARTER KIT KIT [SCHWABE NORTH AMERICA, INC.]10Legacy NDC20241023_c267c869-631e-44e4-8cbe-a4da5f305ace.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-5273-9534995273091 BOTTLE, PLASTIC in 1 CARTON (53499-5273-9) > 240 mL in 1 BOTTLE, PLASTIC2006-01-010000-00-00NoNoCurrent