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 102 of 359 · 7,168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWALGREENS CO.9b756e4e-6c56-43aa-a5bc-5b649440e7592026-01-20WarningsExact identifier
unii: 362O9ITL9D
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALGREENS CO.5a58d620-a0ec-48d7-92dd-3f3f78ec10ea2026-01-20WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATECARDINAL HEALTH 110, LLC. DBA LEADER 70000a8460fc9-2d08-4e5f-8dd3-5135ecda59232026-01-20WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Leader Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. dba Leaderb74a8baa-c7a2-4eed-8202-888d8ba829b92026-01-20WarningsExact identifier
unii: 362O9ITL9D
365 WHOLE FOODS MARKET GUAIFENESINGUAIFENESINWhole Foods Market, Inc.7c890031-8188-48be-bb69-06db0e01a0c02026-01-20WarningsExact identifier
unii: 495W7451VQ
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Companyfc258e1f-5447-421a-84a8-2d9e72fd60992026-01-20WarningsExact identifier
unii: 362O9ITL9D
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services Inc0a651316-623e-41eb-ab3a-641f5d8074252026-01-20WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
equate pain relieverACETAMINOPHENWal-Mart Stores Incd4e438c6-80dd-4531-91e6-bc4ca7a8570f2026-01-20WarningsExact identifier
unii: 362O9ITL9D
Walgreens Maximum Strength Non Drowsy Day and Night Cold and FluWALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWalgreens579c47c8-6366-4785-9680-d3986ce9641d2026-01-19WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and ColdWALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLDWalgreensdd61c9d3-0b70-450e-9525-282710b383cc2026-01-19WarningsExact identifier
application number: M012
Unishield Extra Strength Non-AspirinACETAMINOPHENUnishieldba0ec1eb-db85-6a7f-e053-2995a90aafe52026-01-19WarningsExact identifier
unii: 362O9ITL9D
Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC48bf7422-38ef-d4b4-e063-6294a90aa3ab2026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensfc670515-a820-4ea7-8786-8ae710798b312026-01-19WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREENS9dece7b1-00b1-2499-e053-2a95a90a0be32026-01-19WarningsExact identifier
application number: M012
unii: TC2D6JAD40
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYf000d0b5-8ee8-4db0-99fe-aae5ed20c98e2026-01-19WarningsExact identifier
unii: TC2D6JAD40
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreens2dba2bec-e0e3-4910-89c5-ebc093e05bec2026-01-19WarningsExact identifier
application number: M012
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVEREACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreensca3c1eb4-6099-5e5f-e053-2995a90ab61b2026-01-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENSfe6dff90-18f1-491e-84b9-cc74bb1831ba2026-01-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens Companyec8c73d5-b190-432a-92c6-68ea0fc86ea62026-01-19WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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