FDA.reportPublic FDA data

Umcka ColdCare

Manufacturer
ProSolutions Inc. | Schwabe North America, Inc.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:39:51

Label at a glance#

ProductUmcka ColdCare Day Plus Night
Active ingredientPELARGONIUM SIDOIDES ROOT, HUMULUS LUPULUS WHOLE, CHAMOMILE, PASSIFLORA INCARNATA WHOLE
Label structure25 sections

Label contents#

Full prescribing information#

1040-1

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients panelActive Ingredients panel

1040-1

INACTIVE INGREDIENT SECTION

Inactive Ingredients panelInactive Ingredients panel

1040-1

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration panelDosage and Administration panel

1040-1

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

1040-1

WARNINGS SECTION

Warnings PanelWarnings Panel

1040-1

OTC - ASK DOCTOR SECTION

Ask Doctor panelAsk Doctor panel

1040-1

OTC - STOP USE SECTION

Stop Use panelStop Use panel

1040-1

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy PanelPregnancy Panel

1040-1

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach panelKeep out of reach panel

1040-1

OVERDOSAGE SECTION

Over dosage panelOver dosage panel

1040-1

OTC - PURPOSE SECTION

Purpose PanelPurpose Panel

1050-1

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients panelActive Ingredients panel

1050-1

INACTIVE INGREDIENT SECTION

Inactive Ingredients panelInactive Ingredients panel

1050-1

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration panelDosage and Administration panel

1050-1

INDICATIONS & USAGE SECTION

Indications and Usage panelIndications and Usage panel

1050-1

WARNINGS SECTION

Warnings panelWarnings panel

1050-1

OTC - ASK DOCTOR SECTION

Ask Doctor panelAsk Doctor panel

1050-1

OTC - STOP USE SECTION

Stop use panelStop use panel

1050-1

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy panelPregnancy panel

1050-1

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach panelKeep out of reach panel

1050-1

OVERDOSAGE SECTION

Over dosage panelOver dosage panel

1050-1

OTC - PURPOSE SECTION

Purpose panelPurpose panel

1060-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Panel 1060-1Primary Panel 1060-1

1040-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1040-1 Primary Panel1040-1 Primary Panel

1050-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1050-1 Primary Panel1050-1 Primary Panel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83102-1040UMCKA COLDCARE DAY PLUS NIGHT KIT [PROSOLUTIONS INC.]2Unmatched20250411_f5d9ec67-6771-653d-e053-2995a90a75c3.zip
83102-1050UMCKA COLDCARE DAY PLUS NIGHT KIT [PROSOLUTIONS INC.]2Unmatched20250411_f5d9ec67-6771-653d-e053-2995a90a75c3.zip
83102-1060UMCKA COLDCARE DAY PLUS NIGHT KIT [PROSOLUTIONS INC.]2Unmatched20250411_f5d9ec67-6771-653d-e053-2995a90a75c3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83102-104083102-1040-1
83102-105083102-1050-1
83102-106083102-1060-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PELARGONIUM SIDOIDES ROOTH6J53HEX8EACTIB
ALCOHOL3K9958V90MIACT
TURMERIC856YO1Z64FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
HONEYY9H1V576FHIACT
SIRAITIA GROSVENORII FRUITNOU2FB51TWIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEVIA LEAF6TC6NN0876IACT
XYLITOLVCQ006KQ1EIACT
ALCOHOL3K9958V90MIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
TURMERIC856YO1Z64FIACT
HUMULUS LUPULUS WHOLE912A6Q1N4AACTIB
CHAMOMILEFGL3685T2XACTIB
PELARGONIUM SIDOIDES ROOTH6J53HEX8EACTIB
PASSIFLORA INCARNATA WHOLER48E2W2LMOACTIB

Source Document#

Source XML

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
326c9a3a-76b2-2199-e063-6394a90a6a66f5d9ec67-6771-653d-e053-2995a90a75c32025-04-10WarningsExact identifier
spl id: 326c9a3a-76b2-2199-e063-6394a90a6a66
spl set id: f5d9ec67-6771-653d-e053-2995a90a75c3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.