FDA.reportPublic FDA data

Multi Symptom Wal Flu Severe Cold

Product NDC
0363-5470
11-digit product format
003635470
Labeler code
0363
Product ID
0363-5470_446a3d6e-8f81-4689-e063-6394a90ac2cf
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
WALGREEN CO.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Multi Symptom Wal Flu Severe Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal 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
1189316Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c0f3f1e-25d1-4d73-9cd7-42708aa66dcbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5470-06Multi Symptom Wal Flu Severe Cold6 in 1 CARTONPOWDER, FOR SOLUTION68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-5470-06EA - Each0363-5470f4f6e9b0-34a0-4fbd-8290-870615698e9f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5470MULTI SYMPTOM WAL FLU SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [WALGREEN CO.]7Current NDC, Legacy NDC, 1 package rows20241113_9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb.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 24 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb8
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb8
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb8
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb8
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5470-06003635470066 POWDER, FOR SOLUTION in 1 CARTON (0363-5470-06) 2018-05-310000-00-00NoNoCurrent