FDA.reportPublic FDA data

TopCare Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu Relief

Product NDC
36800-562
11-digit product format
368000562
Labeler code
36800
Product ID
36800-562_19826132-4b2e-4c61-87f1-50ccb4d8173f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen ,Dextromethorphan Hydrobromide and Phenylephrine HCl ,Acetaminophen,Dextromethorphan HBR,Doxylamine succinate
Dosage form
KIT
Labeler
TopCare Health
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-03-06
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-562-082024-01-30C16284748780-11030e365-2d57-111a-e063-dadaa90a10e2TopCare health ™ Day and Night Combination Pack Non-Drowsy Daytime Cold and Flu Relief Single Serve Cups Nighttime Cold and Flu Relief Single Serve Cups

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-562-08TopCare Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu ReliefDay and Night Combo Pack1 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-562TOPCARE HEALTH NON DROWSY DAYTIME COLD AND FLU RELIEF AND NIGHTTIME COLD AND FLU RELIEF DAY AND NIGHT COMBO PACK (ACETAMINOPHEN ,DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HCL ,ACETAMINOPHEN,DEXTROMETHORPHAN HBR,DOXYLAMINE SUCCINATE) KIT [TOPCARE HEALTH]4Legacy NDC, 1 package rows20221201_90358b3c-63c9-4aef-a241-9a6e588535d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119242{1 (acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } PackGPCK90358b3c-63c9-4aef-a241-9a6e588535d54
2119242{1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } PackPSN90358b3c-63c9-4aef-a241-9a6e588535d54
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN90358b3c-63c9-4aef-a241-9a6e588535d54
1805288acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral SolutionPSN90358b3c-63c9-4aef-a241-9a6e588535d54
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD90358b3c-63c9-4aef-a241-9a6e588535d54
1805288acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral SolutionSCD90358b3c-63c9-4aef-a241-9a6e588535d54
2119242{1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution) } PackSY90358b3c-63c9-4aef-a241-9a6e588535d54
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSY90358b3c-63c9-4aef-a241-9a6e588535d54
1805288acetaminophen 650 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG Granules for Oral SolutionSY90358b3c-63c9-4aef-a241-9a6e588535d54
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY90358b3c-63c9-4aef-a241-9a6e588535d54
1805288APAP 650 MG / Dextromethorphan Hydrobromide 30 MG / doxylamine succinate 12.5 MG Powder for Oral SolutionSY90358b3c-63c9-4aef-a241-9a6e588535d54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-562-08368000562081 KIT in 1 KIT (36800-562-08) * 4 CUP in 1 KIT > 1 POWDER, FOR SOLUTION in 1 CUP * 4 CUP in 1 KIT > 1 POWDER, FOR SOLUTION in 1 CUP1 kit2019-03-060000-00-00NoNoCurrent