FDA.reportPublic FDA data

Walgreen Severe Multi-Symptom Cough Cold Flu

Product NDC
0363-6300
11-digit product format
003636300
Labeler code
0363
Product ID
0363-6300_44e14d6a-18b9-8a8b-e063-6294a90a0d16
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREENS
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Walgreen Severe Multi-Symptom Cough Cold Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116572Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b48d93fe-bb60-493f-8d1a-b2dc864203c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6300-08Walgreen Severe Multi-Symptom Cough Cold Flu1 in 1 CARTONLIQUID14
0363-6300-08Walgreen Severe Multi-Symptom Cough Cold Flu237 mL in 1 BOTTLELIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6300WALGREEN SEVERE MULTI-SYMPTOM COUGH COLD FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREENS]3Current NDC, Legacy NDC, 2 package rows20241115_b48d93fe-bb60-493f-8d1a-b2dc864203c4.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 33 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEGeri-Care Pharmaceutical Corpb670a898-2360-76e2-e053-2a95a90a33802025-11-17WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ec902e52-0f48-4a61-b67d-17e1c14616192025-11-15WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.72babe91-2586-4f05-ae90-6debfd23aa5d2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINStrategic Sourcing Services LLC3c7883da-6f51-4716-b012-0e33d239a60e2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINSam's West Inc3b84746f-05ab-4f88-b9ae-efb8c5dfc2332025-11-15WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWalgreen Companya482e715-bec0-44a4-bb0e-ea5f5fda558e2025-11-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf1157dbc-d86c-4554-954c-60a74674ff6b2025-11-15WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINENuCare Pharmaceuticals,Inc.437e4fd9-c7d9-77d6-e063-6294a90a22b72025-11-13WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company7f78028a-484b-48b3-a37a-1e0b055bbefc2025-11-13WarningsExact identifier
application number: M013
OneSsip AcetaminophenACETAMINOPHENMEDWISE LIFESCIENCES INC.3f88de0f-6cf6-3580-e063-6294a90abcb42025-11-12WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b1a31-353d-af20-e063-6294a90aa9072025-11-11WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen4b829607-f5fb-427f-83b5-5b6b9c44ebeb2025-11-11WarningsExact identifier
application number: M013
Pamprin Max Menstrual Pain ReliefACETAMINOPHEN AND ASPIRIN AND CAFFEINEFocus Consumer Healthcare, LLC5bd4b935-f003-7df8-e053-2a91aa0a5d792025-11-10WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp61e50135-a7c2-4a86-8a1a-d47b41d3f9d12025-11-07WarningsExact identifier
application number: M013
Childrens ChewablesACETAMINOPHENStrategic Sourcing Services LLCaf2cbbaf-9b73-440a-bc88-a790cafccc6b2025-11-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.39e142a7-8590-4e1e-8319-6904fb57cc8a2025-11-06WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC42321456-d7dd-3b51-e063-6394a90ac2922025-11-05WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENFamily Dollar Services Inc76058eb3-2d3f-4414-87df-7167cd27d26b2025-11-05WarningsExact identifier
application number: M013
Children Pain and Fever ReliverACETAMINOPHENTarget Corporation1116f808-f61e-47ec-b0d0-d4be5aa905be2025-11-04WarningsExact identifier
application number: M013
Pain Reliever Dye FreeACETAMINOPHENTIME CAP LABORATORIES, INC.42c4f0b2-6483-0f3c-e063-6294a90a140f2025-11-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNb48d93fe-bb60-493f-8d1a-b2dc864203c44
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDb48d93fe-bb60-493f-8d1a-b2dc864203c44
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYb48d93fe-bb60-493f-8d1a-b2dc864203c44
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYb48d93fe-bb60-493f-8d1a-b2dc864203c44
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYb48d93fe-bb60-493f-8d1a-b2dc864203c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6300-08003636300081 BOTTLE in 1 CARTON (0363-6300-08) / 237 mL in 1 BOTTLE1 bottle2022-11-010000-00-00NoNoCurrent