FDA.reportPublic FDA data

DAYTIME NIGHTTIME COLD/FLU RELIEF

Product NDC
46084-121
11-digit product format
460840121
Labeler code
46084
Product ID
46084-121_c75e18ea-fbbe-477e-a961-6ce6d1954cab
Type
HUMAN OTC DRUG
Nonproprietary name
DAYTIME NIGHTTIME COLD/FLU RELIEF
Dosage form
KIT
Labeler
A P J Laboratories Limited
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46084-121-012019-11-27C16284748780-19855d018-dffa-cd31-e053-dbdaa90ab51add372e00-c378-43bd-974c-f44f8adddb57

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-121-01DAYTIME NIGHTTIME COLD/FLU RELIEFA P J1 in 1 PACKAGEKIT11
46084-122-20DAYTIME NIGHTTIME COLD/FLU RELIEFA P J20 in 1 BLISTER PACKTABLET205 mg1
46084-123-20DAYTIME NIGHTTIME COLD/FLU RELIEFA P J20 in 1 BLISTER PACKTABLET206.25 mg1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0ADAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-121DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1Legacy NDC, 3 package rows20130601_dd372e00-c378-43bd-974c-f44f8adddb57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1425331{1 (acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKdd372e00-c378-43bd-974c-f44f8adddb571
14253311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan HBr 15 MG Oral Tablet) PackPSNdd372e00-c378-43bd-974c-f44f8adddb571
1425315acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan HBr 15 MG Oral TabletPSNdd372e00-c378-43bd-974c-f44f8adddb571
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNdd372e00-c378-43bd-974c-f44f8adddb571
1425315acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan hydrobromide 15 MG Oral TabletSCDdd372e00-c378-43bd-974c-f44f8adddb571
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDdd372e00-c378-43bd-974c-f44f8adddb571
14253311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan HBr 15 MG Oral Tablet) PackSYdd372e00-c378-43bd-974c-f44f8adddb571
1425315APAP 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan hydrobromide 15 MG Oral TabletSYdd372e00-c378-43bd-974c-f44f8adddb571
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYdd372e00-c378-43bd-974c-f44f8adddb571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46084-121-01460840121011 in 1 PACKAGEHistorical
46084-122-204608401222020 in 1 BLISTER PACKHistorical
46084-123-204608401232020 in 1 BLISTER PACKHistorical