FDA.reportPublic FDA data

NITETIME COUGH

Product NDC
71027-041
11-digit product format
710270041
Labeler code
71027
Product ID
71027-041_1d0151fa-01e3-4cfa-9e7e-86e31ecfd8c4
Type
HUMAN OTC DRUG
Nonproprietary name
NITETIME 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; DOXYLAMINE SUCCINATE
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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71027-041-062020-09-27C16284748780-1ab0e2407-3079-f274-e053-dbdaa90a6471NITETIME COUGH
71027-041-062020-09-25C16284748780-1ab0e2407-3079-f274-e053-dbdaa90a6471NITETIME COUGH
71027-041-062020-07-22C16284748780-1ab0e2407-3079-f274-e053-dbdaa90a6471NITETIME COUGH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-041-06NITETIME COUGH177 mL in 1 BOTTLELIQUID1772
71027-041-06NITETIME COUGH1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-041NITETIME COUGH LIQUID [KINGSTON PHARMA LLC]2Legacy NDC, 2 package rows20190206_de9c6c1d-ff69-49c2-8c18-2a556d229836.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 SolutionPSNde9c6c1d-ff69-49c2-8c18-2a556d2298362
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDde9c6c1d-ff69-49c2-8c18-2a556d2298362
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYde9c6c1d-ff69-49c2-8c18-2a556d2298362
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYde9c6c1d-ff69-49c2-8c18-2a556d2298362
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYde9c6c1d-ff69-49c2-8c18-2a556d2298362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
71027-041-0671027004106177 mL in 1 BOTTLE177 mlHistorical