FDA.reportPublic FDA data

NDC 0363-5481 - Multi Symptom Severe Cold and Nighttime Severe Cold and Cough

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
0363-5481
Package NDCs from labels
0363-5481-06
Manufacturer
WALGREEN CO.
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough - WALGREEN CO.WALGREEN CO.2025-12-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5481-06Multi Symptom Severe Cold and Nighttime Severe Cold and Cough6 in 1 CARTONPOWDER, FOR SOLUTION10 mg8
0363-5481-06Multi Symptom Severe Cold and Nighttime Severe Cold and Cough1 in 1 PACKETPOWDER, FOR SOLUTION610 mg8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5481MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREEN CO.]7Unmatched20241115_6c4ab613-a587-4ec4-9986-f1d000bc2d23.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 29 of 331 · 6,619 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATESelect Consumer Group3ca96ed9-d9af-dbfe-e063-6394a90a29322026-07-03WarningsExact identifier
unii: 362O9ITL9D
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINESelect Consumer Group3caa4adf-abe3-67c3-e063-6294a90a87a42026-07-03WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
CONTAC COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEVESPYR BRANDS LLCf72d510b-e370-4137-8d4f-d9afd5d19a192026-07-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Butalbital, Acetaminophen, and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.bf333509-bf2b-43fa-9eb5-5193e442f3282026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013
Nite time Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf8f84be1-e3b1-4e93-8e1c-ee93e1f4af132026-07-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
unii: 9D2RTI9KYH
AspirinASPIRINUnited Natural Foods, Inc. dba UNFI19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff62026-07-02WarningsExact identifier
application number: M013
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENMajor Pharmaceuticals1d52272f-a607-4002-a61c-341964522b822026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
8 HR Arthritis PainACETAMINOPHENDr. Reddy's Laboratories Inc.8e780c23-997c-b960-226e-954037baad4b2026-07-01WarningsExact identifier
unii: 362O9ITL9D
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
pain relief EXTRA STRENGTHACETAMINOPHENMeijer Distribution, Inc.ae84eb7e-a70b-4311-b2dc-ad153047a5162026-07-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHospira, Inc.559a0a8c-a8fe-40a5-b196-21f9308780ab2026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.161c34b4-3cd2-40b4-b13e-ad980ad4249c2026-07-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)437cd589-f5da-4390-b178-609d4537eaab2026-07-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions30527e49-6648-44f3-97b2-9c51783ac0032026-07-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aspirin 325 mgASPIRINHi-Tech Nutraceuticals, LLCb3426a9a-ea99-da30-e053-2995a90a1e4b2026-07-01WarningsExact identifier
application number: M013
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPd36f86e2-fe0f-4b74-a5bf-b23082d72da22026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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