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 80 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpd0dd4a75-da65-4c66-b65f-54ee141008462025-12-05WarningsExact identifier
application number: M012
Basic Care Cherry Cough DropsMENTHOLAmazon.comc0588221-0c84-66d8-e053-2995a90a874f2025-12-05WarningsExact identifier
application number: M012
Basic Care Honey Lemon Cough DropsMENTHOLAmazon.comc0937b13-f679-a764-e053-2a95a90abf892025-12-05WarningsExact identifier
application number: M012
Basic Care SF Menthol Cough DropsMENTHOLAmazon.comc0946295-7cf0-1bd8-e053-2a95a90af5af2025-12-05WarningsExact identifier
application number: M012
Basic Care SF Honey Lemon Cough DropsMENTHOLAmazon.comcf82fb0b-1b4d-def1-e053-2995a90a6fd92025-12-05WarningsExact identifier
application number: M012
G-DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis7a4e1d64-2510-405f-a1dc-e02a803b6fbd2025-12-05WarningsExact identifier
application number: M012
Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEChain Drug Manufacturing Assnce658dd5-b683-436e-b16b-0c06f6f87fd92025-12-04WarningsExact identifier
application number: M012
Quality Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa87ba15f-b5a9-4983-a721-ca7f705aea862025-12-04WarningsExact identifier
application number: M012
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsExact identifier
application number: M012
Childrens Mucus Relief Chest CongestionGUAIFENESINChain Drug Manufacturing Assn034d39c0-9aad-4dff-a158-a041b9f0504f2025-12-04WarningsExact identifier
application number: M012
Quality ChoiceOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd01b8fb6-1ddf-4901-bda6-ae608e94a6a42025-12-04WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEChain Drug Manufacturing Assn06822a28-3f82-471d-8db5-c5981b263a032025-12-04WarningsExact identifier
application number: M012
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsExact identifier
application number: M012
Daytime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Incfd5c20ed-5520-4db0-bfd4-995f043af2a42025-12-04WarningsExact identifier
application number: M012
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a2b30c27-b836-f09f-e053-2995a90ac3832025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast FizzASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.a37c9d9d-52db-23ff-e053-2995a90a8f762025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a68df74d-dd26-3ae9-e053-2995a90a08d62025-12-04WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.55662ada-677e-4048-9529-5bca440763162025-12-04WarningsExact 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