FDA.reportPublic FDA data

Umcka ColdCare Alcohol-Free

Product NDC
53499-5271
11-digit product format
534995271
Labeler code
53499
Product ID
53499-5271_26f727d1-d05c-4995-8ffc-93fc699e6d42
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
LIQUID
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-02-02
Marketing end
2027-02-28
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/30mL
NDC exclude flag
No
Current FDA listing
Yes

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 packagepackage53499-527153499-5271-8DDiscontinued 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 packagepackage53499-527153499-5271-8DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53499-527153499-5271-8DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Additional Listing Data#

Finished product
Yes
Brand name base
Umcka ColdCare Alcohol-Free

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c647ae9-6c14-4661-aba3-53e9e4756edcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5271-4Umcka ColdCare Alcohol-Free30 mL in 1 BOTTLE, DROPPERLIQUID3012
53499-5271-4Umcka ColdCare Alcohol-Free1 in 1 CARTONLIQUID112
53499-5271-8Umcka ColdCare Alcohol-Free1 in 1 CARTONLIQUID112
53499-5271-8Umcka ColdCare Alcohol-Free60 mL in 1 BOTTLE, DROPPERLIQUID6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-5271-4ML - Milliliter53499-5271b35f7ac7-7a89-4a08-928e-98d9838aa5cd12025-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EUMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY PRODUCTS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY PRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [NATURE'S WAY PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5271UMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA, INC.]12Current NDC, Legacy NDC, 4 package rows20241027_5c647ae9-6c14-4661-aba3-53e9e4756edc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Umcka ColdCare Alcohol-FreePELARGONIUM SIDOIDESSchwabe North America, Inc.5c647ae9-6c14-4661-aba3-53e9e4756edc2024-10-25WarningsExact identifier
ndc (product): 53499-5271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-5271-4534995271041 BOTTLE, DROPPER in 1 CARTON (53499-5271-4) / 30 mL in 1 BOTTLE, DROPPER2009-02-022027-02-28NoNoCurrent
53499-5271-8534995271081 BOTTLE, DROPPER in 1 CARTON (53499-5271-8) > 60 mL in 1 BOTTLE, DROPPER2009-02-020000-00-00NoNoCurrent