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 65 of 331 · 6,619 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Cough DMDEXTROMETHORPHAN POLISTIREXCardinal Health 110, LLC. dba Leadera07b70d0-3842-4ea6-abb4-95b4638d5e552026-04-08WarningsExact identifier
unii: 9D2RTI9KYH
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack092f4694-98df-41bd-b37c-afbcda087e562026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: 04JA59TNSJ
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka3cbf0c1-b589-4e4a-b355-01bddb7e49552026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf7b554ab-2996-4cf0-a498-01cd5ef5df4f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5431c1bf-469b-4944-a558-52d098c9b0f02026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5d6de20-c195-4b97-963a-2f3832e50b492026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6fae7c90-1d80-4eb8-bbb8-8f945884f5c62026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC76e19b9a-3bdb-479a-9503-9e8250109c842026-04-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
application number: M013
unii: 362O9ITL9D
BanophenDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.0f52270a-b11a-4fa1-aac2-9fe5ff6254192026-04-06WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HClDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.d3f769d7-3cbb-4469-bff8-2015619ee1152026-04-06WarningsExact identifier
unii: TC2D6JAD40
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.7fc05877-6ce8-4b2e-afba-9e043150e1c52026-04-06WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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