careone daytime nighttime severe cold and flu

Product NDC
41520-597
Requested package NDC
41520-597-02
11-digit product format
415200597
Labeler code
41520
Product ID
41520-597_c0c8e53f-7805-49f4-8217-5ddc7546b5ee
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl
Dosage form
KIT
Labeler
American Sales Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-10-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-59741520-597-02DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-597CAREONE DAYTIME NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [AMERICAN SALES COMPANY]3Legacy NDC20241116_c0c8e53f-7805-49f4-8217-5ddc7546b5ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-597-02415200597021 KIT in 1 KIT (41520-597-02) * 355 mL in 1 BOTTLE (41520-561-40) * 355 mL in 1 BOTTLE (41520-713-40) 1 kit2018-10-010000-00-00NoNoCurrent