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

Additional Listing Data#

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

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

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