FDA.reportPublic FDA data

Daytime Cough

Product NDC
71027-040
11-digit product format
710270040
Labeler code
71027
Product ID
71027-040_a2ed7897-3b8f-4ec9-8def-fb8bb6641c5a
Type
HUMAN OTC DRUG
Nonproprietary name
Daytime Cough
Dosage form
LIQUID
Route
ORAL
Labeler
KINGSTON PHARMA LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-03-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL
NDC exclude flag
No
Listing certified through
2020-12-31
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
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
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
71027-040-062020-09-27C16284748780-1ab0e2407-34c4-f274-e053-dbdaa90a6471Daytime Cough
71027-040-062020-09-25C16284748780-1ab0e2407-34c4-f274-e053-dbdaa90a6471Daytime Cough
71027-040-062020-07-22C16284748780-1ab0e2407-34c4-f274-e053-dbdaa90a6471Daytime Cough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-040-06Daytime Cough1 in 1 CARTONLIQUID12
71027-040-06Daytime Cough177 mL in 1 BOTTLELIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-040DAYTIME COUGH LIQUID [KINGSTON PHARMA LLC]2Legacy NDC, 2 package rows20190206_5f7ad8db-c9f9-4462-99a7-eee24bd0cb62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN5f7ad8db-c9f9-4462-99a7-eee24bd0cb622
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD5f7ad8db-c9f9-4462-99a7-eee24bd0cb622
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY5f7ad8db-c9f9-4462-99a7-eee24bd0cb622
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY5f7ad8db-c9f9-4462-99a7-eee24bd0cb622
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY5f7ad8db-c9f9-4462-99a7-eee24bd0cb622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71027-040-06710270040061 in 1 CARTONHistorical