FDA.reportPublic FDA data

Daytime Nighttime Multi Symptom Cold

Product NDC
0363-4200
11-digit product format
003634200
Labeler code
0363
Product ID
0363-4200_2e9e5fe3-b9d8-4399-b314-ba8d210b7f8e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl,Acetaminophen,Diphenhydramine HCl, Phenylephrine HCl
Dosage form
KIT
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-31
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Daytime Nighttime Multi Symptom Cold
Brand name suffix
Childrens
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043543Internal RxNorm lookup
1375932Internal RxNorm lookup
2637728Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da4c36f5-ec79-4489-bb18-8ddab79c34bdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

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
0363-4070-04Daytime Nighttime Multi Symptom ColdChildrens118 mL in 1 BOTTLE, PLASTICLIQUID118 mL2.5 mg in 5mL8
0363-4200-08Daytime Nighttime Multi Symptom ColdChildrens1 in 1 KITKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4200-08ML - Milliliter0363-4200b3faa9b6-073d-406b-9cca-4ca2107232cb12015-11-12

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4200DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]7Current NDC, Legacy NDC, 3 package rows20240622_da4c36f5-ec79-4489-bb18-8ddab79c34bd.zip

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 12 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637728{1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCKda4c36f5-ec79-4489-bb18-8ddab79c34bd8
26377281 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) PackPSNda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDda4c36f5-ec79-4489-bb18-8ddab79c34bd8
26377281 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYda4c36f5-ec79-4489-bb18-8ddab79c34bd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4060-0400363406004118 mL in 1 BOTTLE, PLASTIC118 mlHistorical
0363-4070-0400363407004118 mL in 1 BOTTLE, PLASTIC118 mlHistorical
0363-4200-08003634200081 KIT in 1 KIT (0363-4200-08) * 118 mL in 1 BOTTLE, PLASTIC (0363-4070-04) * 118 mL in 1 BOTTLE, PLASTIC (0363-4060-04) 1 kit2014-12-310000-00-00NoNoCurrent