Umcka ColdCare Alcohol-Free

Product NDC
53499-6271
11-digit product format
534996271
Labeler code
53499
Product ID
53499-6271_8a8ed8f1-8e8c-4a7f-bd76-a22d795ed288
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
LIQUID
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-03-21
Marketing end
2027-02-28
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/59mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Umcka ColdCare Alcohol-Free

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/59mL

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
5e290fb1-4dd6-4a7e-a1e5-41e2863bc34aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6271-8Umcka ColdCare Alcohol-Free1 in 1 CARTONLIQUID12
53499-6271-8Umcka ColdCare Alcohol-Free59 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-6271-8ML - Milliliter53499-62712919f487-14dc-42e7-a66c-2a8efbf42dc212025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6271UMCKA COLDCARE ALCOHOL-FREE (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA, INC.]2Current NDC, 2 package rows20241027_5e290fb1-4dd6-4a7e-a1e5-41e2863bc34a.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.5e290fb1-4dd6-4a7e-a1e5-41e2863bc34a2024-10-25WarningsExact identifier
ndc (product): 53499-6271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-6271-8534996271081 BOTTLE, DROPPER in 1 CARTON (53499-6271-8) / 59 mL in 1 BOTTLE, DROPPER2023-03-212027-02-28NoNoHistorical