TopCare Day Time Nite Time Cold and Flu Relief

Product NDC
36800-301
11-digit product format
368000301
Labeler code
36800
Product ID
36800-301_9933ade0-55aa-40c9-a808-79363323b129
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-08
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Day Time Nite Time Cold and Flu Relief
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-301-02TopCare Day Time Nite Time Cold and Flu Relief1 in 1 CARTONKIT15
36800-459-40TopCare Day Time Nite Time Cold and Flu Relief355 mL in 1 BOTTLESOLUTION355 mL650 mg in 30mL5
36800-522-40TopCare Day Time Nite Time Cold and Flu Relief355 mL in 1 BOTTLESOLUTION355 mL5 mg in 15mL5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2687211{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution) } PackGPCKc00ff684-acaf-4fbe-bc74-7e48751b927d5
26872111 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) PackPSNc00ff684-acaf-4fbe-bc74-7e48751b927d5
1042675acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSNc00ff684-acaf-4fbe-bc74-7e48751b927d5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNc00ff684-acaf-4fbe-bc74-7e48751b927d5
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral SolutionPSNc00ff684-acaf-4fbe-bc74-7e48751b927d5
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNc00ff684-acaf-4fbe-bc74-7e48751b927d5
1042675acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDc00ff684-acaf-4fbe-bc74-7e48751b927d5
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDc00ff684-acaf-4fbe-bc74-7e48751b927d5
2604561acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSCDc00ff684-acaf-4fbe-bc74-7e48751b927d5
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDc00ff684-acaf-4fbe-bc74-7e48751b927d5
26872111 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 mL Oral Solution) PackSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1042675acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
2604561acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1042675acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1042675APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
2604561APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYc00ff684-acaf-4fbe-bc74-7e48751b927d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-301-02368000301021 KIT in 1 CARTON (36800-301-02) * 355 mL in 1 BOTTLE (36800-459-40) * 355 mL in 1 BOTTLE (36800-522-40) 1 kit2018-09-080000-00-00NoNoCurrent
36800-459-4036800045940355 mL in 1 BOTTLE355 mlHistorical
36800-522-4036800052240355 mL in 1 BOTTLE355 mlHistorical