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 99 of 331 · 6,619 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucosan Multi-Symptom CherryDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26b8c06d-4a72-3979-e063-6394a90a96d72026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Mucosan Max with AcetaminophenACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26a4861b-5d8e-9ec6-e063-6394a90af5772026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucosan Severe Multi-SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.26a69342-f65f-cb46-e063-6394a90ade102026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non DrowsyASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a355d987-77ce-9e32-e053-2995a90a64312026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e17eb929-209d-a2d1-e053-2a95a90a4cf32026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c1fae6c7-bbac-1320-e053-2a95a90aac5a2026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
VANACOF XP Cough / Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGM Pharmaceuticals, INC0b3a8cc1-a49f-e1e5-e063-6394a90a1c062026-01-08WarningsExact identifier
unii: 9D2RTI9KYH
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc32026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Diphenhydramine HClDIPHENHYDRAMINE HCLINVAHEALTH INCe4e4004f-77e3-569d-e053-2a95a90a73fe2026-01-08WarningsExact identifier
unii: TC2D6JAD40
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: 04JA59TNSJ
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAdvanced Rx of Tennessee, LLC4871c36f-229b-4c12-e063-6394a90a028e2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
unii: 04JA59TNSJ
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC93b6dfdf-ba6e-4ea6-ab85-5ac121e331012026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Flex Drops 2024FLEX DROPSProfessional Complementary Health Formulase857670f-de84-494e-9e81-80144792d1fa2026-01-08WarningsExact identifier
unii: 660YQ98I10
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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