FDA.reportPublic FDA data

NDC 0363-4060 - Daytime Nighttime Multi Symptom Cold Childrens

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
0363-4060
Package NDCs from labels
0363-4060-04
Manufacturer
Walgreens
Effective date
2026-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Daytime Nighttime Multi Symptom Cold Childrens - WalgreensWalgreens2026-03-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4060-04Daytime Nighttime Multi Symptom ColdChildrens118 mL in 1 BOTTLE, PLASTICLIQUID118 mL5 [arb'U] in 10mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4060DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]7Unmatched20240622_da4c36f5-ec79-4489-bb18-8ddab79c34bd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
GUAIFENESINACTIVE INGREDIENT495W7451VQDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
GUAIFENESINACTIVE MOIETY495W7451VQDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]2

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 67 of 360 · 7,186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INC07b9854d-1ec6-4c8a-983e-96ed1e2de1c22026-04-20WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Pamprin Multi-Symptom Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFocus Consumer Healthcare, LLC60b3286d-5698-df50-e053-2991aa0afbe22026-04-20WarningsExact identifier
unii: 362O9ITL9D
Tecnu CalagelDIPHENHYDRAMINE HYDROCHLORIDETec Laboratories Inc.8bc9cbfe-1dd4-18ed-e053-2a95a90a79662026-04-20WarningsExact identifier
unii: TC2D6JAD40
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLC73c1059b-0c7d-42ef-9827-f018858fc4472026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
good sense mucus erGUAIFENESINRedpharm Drug4fb57f87-f761-b52e-e063-6294a90ae4ee2026-04-18WarningsExact identifier
unii: 495W7451VQ
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
unii: 362O9ITL9D
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC.bb7701aa-f482-69e7-e053-2995a90a71b82026-04-17WarningsExact identifier
unii: TC2D6JAD40
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
unii: 495W7451VQ
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
unii: 495W7451VQ
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEFamily Dollar Services Incd9050ed0-455d-4903-8f30-3e9ec9a128862026-04-17WarningsExact identifier
unii: 362O9ITL9D
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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