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 168 of 278 · 5,545 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
unii: 588X2YUY0A
unii: A2I8C7HI9T
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINEHaleon US Holdings LLC910d7254-d0f4-4c5c-a26e-7f8acecbe02d2025-03-11WarningsExact identifier
unii: 362O9ITL9D
Sudafed PE Head Congestion Plus PainIBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC76513fb2-7323-4f1f-8a10-92f8f603cf972025-03-10WarningsExact identifier
unii: 04JA59TNSJ
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
unii: 9D2RTI9KYH
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
8HR Arthritis PainACETAMINOPHENFSA STORE INC.06446e9a-0e83-0623-e063-6294a90ac4032025-03-07WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
unii: 362O9ITL9D
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: 04JA59TNSJ
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
unii: ND2M416302
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLC170e63f1-23f4-4839-ab89-b81832d94a562025-03-05Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Redicare Nasal and Sinus DecongestantREDICARE NASAL AND SINUS DECONGESTANTRedicare LLC2f24be68-f30e-d916-e063-6294a90a7e312025-03-04WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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