FDA.reportPublic FDA data

Umcka Original ColdCare

Product NDC
53499-6270
11-digit product format
534996270
Labeler code
53499
Product ID
53499-6270_90a7c95c-54f3-430d-998a-33f578756e6c
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
LIQUID
Route
ORAL
Labeler
Schwabe North America
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-04-06
Marketing end
2026-08-31
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/30mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Umcka Original ColdCare

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
4b1fbd9f-9780-4274-9e02-d0ca96c19490Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6270-4Umcka Original ColdCare1 in 1 CARTONLIQUID12
53499-6270-4Umcka Original ColdCare30 mL in 1 BOTTLE, DROPPERLIQUID302
53499-6270-8Umcka Original ColdCare59.1 mL in 1 BOTTLE, DROPPERLIQUID59.12
53499-6270-8Umcka Original ColdCare1 in 1 CARTONLIQUID12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6270-4ML - Milliliter53499-6270ea4360f6-b00f-4349-9c1e-6bb944f0e3a412025-09-12
53499-6270-8ML - Milliliter53499-6270dcf1852d-6d55-4ae6-ad37-80e715b0241b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6270UMCKA ORIGINAL COLDCARE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA]2Current NDC, 4 package rows20241031_4b1fbd9f-9780-4274-9e02-d0ca96c19490.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 Original ColdCarePELARGONIUM SIDOIDESSchwabe North America4b1fbd9f-9780-4274-9e02-d0ca96c194902024-10-29WarningsExact identifier
ndc (product): 53499-6270

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-6270-4534996270041 BOTTLE, DROPPER in 1 CARTON (53499-6270-4) / 30 mL in 1 BOTTLE, DROPPER2023-04-062026-08-31NoNoHistorical
53499-6270-8534996270081 BOTTLE, DROPPER in 1 CARTON (53499-6270-8) / 59.1 mL in 1 BOTTLE, DROPPER2023-04-062026-08-31NoNoHistorical