FDA.reportPublic FDA data

Cold Relief

Product NDC
53499-2060
11-digit product format
534992060
Labeler code
53499
Product ID
53499-2060_b5203371-9bdc-49ab-bf12-fba27ec002eb
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Relief Day Plus Night
Dosage form
KIT
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-05-22
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Relief
Brand name suffix
Day Plus Night
Listing expiration
2026-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b063242-ffd6-48f8-af1e-14bcea5247ecAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-2040-1Cold ReliefDay Plus Night5 g in 1 POUCHPowder5 g1 [hp_X] in 5g4
53499-2040-1Cold ReliefDay Plus Night8 in 1 PACKAGEPowder1 [hp_X] in 5g4
53499-2050-1Cold ReliefDay Plus Night4 in 1 PACKAGEPOWDER2 [hp_X] in 5g4
53499-2050-1Cold ReliefDay Plus Night5 g in 1 POUCHPOWDER5 g2 [hp_X] in 5g4
53499-2060-1Cold ReliefDay Plus Night1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-2060COLD RELIEF DAY PLUS NIGHT KIT [SCHWABE NORTH AMERICA, INC.]3Current NDC, 5 package rows20250321_9b063242-ffd6-48f8-af1e-14bcea5247ec.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
Cold Relief Day Plus NightCOLD RELIEF DAY PLUS NIGHTSchwabe North America, Inc.9b063242-ffd6-48f8-af1e-14bcea5247ec2025-07-29WarningsExact identifier
ndc (product): 53499-2060

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-2040-1534992040015 g in 1 POUCH5 gHistorical
53499-2050-1534992050014 in 1 PACKAGEHistorical
53499-2060-1534992060011 KIT in 1 CARTON (53499-2060-1) * 8 POUCH in 1 PACKAGE (53499-2040-1) / 5 g in 1 POUCH * 4 POUCH in 1 PACKAGE (53499-2050-1) / 5 g in 1 POUCH1 kit2024-05-22NoNoCurrent