FDA.reportPublic FDA data

CareOne Night TIme Cold and Flu

Product NDC
41520-084
11-digit product format
415200084
Labeler code
41520
Product ID
41520-084_87dfb140-d122-4b13-8b52-2903d77ce874
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
American Sales Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-11
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-084-34CareOne Night TIme Cold and Flu237 mL in 1 BOTTLESOLUTION2376
41520-084-40CareOne Night TIme Cold and Flu355 mL in 1 BOTTLESOLUTION3556

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-084CAREONE NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 2 package rows20241027_d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de256
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de256
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de256
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de256
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-084-3441520008434237 mL in 1 BOTTLE (41520-084-34) 237 ml2016-04-110000-00-00NoNoCurrent
41520-084-4041520008440355 mL in 1 BOTTLE (41520-084-40) 355 ml2016-04-110000-00-00NoNoCurrent