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 12 of 331 · 6,619 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
unii: 362O9ITL9D
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
unii: 362O9ITL9D
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 660YQ98I10
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM165 DROPSANGELICA ATRO, BALSAM PER, BARIUM MUR, GRINDELIA, KALI BICH, KALI IOD, KALI MUR, SILPHIUM LACBM Private Limited590301da-8f93-3b1e-e063-6394a90a1e722026-08-14WarningsExact identifier
unii: 660YQ98I10
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
unii: TC2D6JAD40
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
rxcui: 2640034
rxcui: 1659960
rxcui: 1189316
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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