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 135 of 327 · 6,539 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime SleepAidDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANY3802d57e-7943-c0c2-e063-6394a90a75802025-11-20WarningsExact identifier
unii: TC2D6JAD40
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Arthritis PainACETAMINOPHENAMERIFOODS TRADING COMPANY3802bc07-3154-f36a-e063-6294a90ac1cc2025-11-20WarningsExact identifier
unii: 362O9ITL9D
ECZEMANICCOLUM SULPHURICUM, KALI BROMATUM, KALI MURIATICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, KALI SULPHURICUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC624d8671-43ce-46a8-87d3-d491fd9ba9132025-11-20WarningsExact identifier
unii: 660YQ98I10
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
unii: 362O9ITL9D
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENHYVEE INC42394377-c874-a955-e063-6294a90ace0b2025-11-20WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENHYVEE INC422796ed-7558-f7e8-e063-6294a90ad1c72025-11-20WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Arthritis PainACETAMINOPHENHYVEE INC3e61b583-c1cb-23bd-e063-6294a90aa0062025-11-20WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENHYVEE INC3e61abe4-b4be-01af-e063-6394a90a8b242025-11-20WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
application number: M013
unii: TC2D6JAD40
unii: 362O9ITL9D
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 660YQ98I10
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
COLD/FLU HPARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUMNatural Creations, Inc.11d945ea-3b03-42cc-b1c0-e4c517e386f62025-11-20WarningsExact identifier
unii: 660YQ98I10
Potassium chloridePOTASSIUM CHLORIDEAdvagen Pharma Ltd8000e242-fe20-4d02-8f7d-97298857cf4c2025-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEAvPAK6bb3f62d-79ce-cee6-8c6c-ee1eb6121f012025-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Inc.5590d577-3a98-49b8-bb12-ddd7f5cfd0802025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC61fe55c2-fc9a-4fae-899a-06601baa78e12025-11-19Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
ASPIRINASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED54e4ae54-caf8-4105-8428-256f56a2f68f2025-11-19WarningsExact identifier
application number: M013

Reported adverse events (FAERS/openFDA)#

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