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 154 of 278 · 5,545 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
unii: 9D2RTI9KYH
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC0bb006f6-c360-4cd5-81e9-0776d99d79e82025-07-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.026e530f-e133-4f20-bac5-354fbb647c9e2025-07-08WarningsExact identifier
unii: 9D2RTI9KYH
good sense pain reliefACETAMINOPHENL. Perrigo Companyaf7ae548-38ad-41d5-b1cb-761cd2e386d32025-07-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCf59016f3-a8f8-4c95-9414-01440f0574d92025-07-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
ACTINEL PEDIATRICDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLC6bb92d74-4893-40b8-af58-eb307155e8762025-07-08WarningsExact identifier
unii: 9D2RTI9KYH
topcare pain reliefACETAMINOPHENTopco Associates LLC6aca88df-d3b5-4a60-b23b-1e66dc41ee7b2025-07-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)776b7c67-56c7-420c-82b2-9a176d9983962025-07-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENGenus Lifesciences Inc.a9fb9779-76a5-407a-a155-84f198004ae22025-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
equate childrens pain and feverACETAMINOPHENWal-Mart Stores Incf15037a5-4e43-4dd6-93b8-b37a1cc22cd62025-07-07WarningsExact identifier
unii: 362O9ITL9D
Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltd39620db9-5099-47f0-93ad-c00e6625c4622025-07-07WarningsExact identifier
unii: ETJ7Z6XBU4
dg health dual back pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Incb52cfead-1cff-4e11-9953-f470fb785c732025-07-07WarningsExact identifier
unii: 362O9ITL9D
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.502b09be-b7e6-4ad7-be17-4c8b0e93b4ab2025-07-07WarningsExact identifier
unii: ND2M416302
Childrens Acetaminophen Oral Liquid Grape FlavorACETAMINOPHENAARNA USA INC.39347f5d-2d3c-0c23-e063-6294a90a3a462025-07-05WarningsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEFresenius Kabi USA, LLCb54a0c59-e5e4-4fd7-ba91-c991ce87b1482025-07-04Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLCf06e4f9d-6cef-b57a-e053-2a95a90a73372025-07-03WarningsExact identifier
unii: ND2M416302
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
unii: ND2M416302
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAurohealth LLCb39fb93f-c140-40ab-8247-9559ef6df50a2025-07-03WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Incbe841460-98b4-4448-a494-09ff161fd1312025-07-02WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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