FDA.reportPublic FDA data

NDC 46084-122 - DAYTIME NIGHTTIME COLD/FLU RELIEF A P J

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
46084-122
Package NDCs from labels
46084-122-20
Manufacturer
A P J Laboratories Limited
Effective date
2013-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DAYTIME NIGHTTIME COLD/FLU RELIEF A P J - A P J Laboratories LimitedA P J Laboratories Limited2013-05-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-122-20DAYTIME NIGHTTIME COLD/FLU RELIEFA P J20 in 1 BLISTER PACKTABLET205 mg1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-122DAYTIME NIGHTTIME COLD/FLU RELIEF A P J (DAYTIME NIGHTTIME COLD/FLU RELIEF) KIT [A P J LABORATORIES LIMITED]1Unmatched20130601_dd372e00-c378-43bd-974c-f44f8adddb57.zip

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 134 of 280 · 5,593 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC913d8bdb-7644-464c-b9a6-55387ff120592025-10-17WarningsExact identifier
unii: 362O9ITL9D
NoHist DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.6aafe912-28ff-442f-8e07-b3c5993ac9432025-10-16WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Medline Alcohol Prep Sterile, LargeISOPROPYL ALCOHOLMedline Industries, LPc9fae7b6-2f4b-490b-9b17-a7297e7380692025-10-16WarningsExact identifier
unii: ND2M416302
Medline Alcohol Prep Sterile, MediumISOPROPYL ALCOHOLMedline Industries, LP9a8584e1-b422-4b77-8464-4e022d578fad2025-10-16WarningsExact identifier
unii: ND2M416302
Medline Alcohol PrepISOPROPYL ALCOHOLMedline Industries, LPb43c0bff-82f8-c18d-e053-2995a90a87162025-10-16WarningsExact identifier
unii: ND2M416302
Butalbital And AcetaminophenBUTALBITAL AND ACETAMINOPHENLarken Laboratories, Inc.326c83fc-afed-45ad-9c87-f47968fa1d2a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEAcella Pharmaceuticals, LLC0c403f27-0b9b-4da3-a66b-1040eff1b2bf2025-10-15Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
unii: 9D2RTI9KYH
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
SEDLAVISOPROPYL ALCOHOLInstock Distributing1b31e3dc-31f3-dffe-e063-6394a90a1c962025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c470960-f78d-19e7-e063-6294a90a49202025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c477028-5cee-b8e2-e063-6394a90afb772025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOLInstock Distributing1c472c35-e241-773f-e063-6294a90abb572025-10-15WarningsExact identifier
unii: ND2M416302
SEDLAVISOPROPYL ALCOHOL WIPESInstock Distributing1c478594-3118-048f-e063-6394a90a35d92025-10-15WarningsExact identifier
unii: ND2M416302
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.