FDA.reportPublic FDA data

Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu

Product NDC
0363-9617
11-digit product format
003639617
Labeler code
0363
Product ID
0363-9617_2cecc341-b4c7-58e0-e063-6394a90a7c75
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl
Dosage form
KIT
Labeler
WALGREENS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-9617-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-9617-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-9617-640efc9e666f02…f202fb6c5f17…

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
Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1110988Internal RxNorm lookup
2549037Internal RxNorm lookup
2560237Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3770976-de73-52b8-e053-2995a90aad4fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9617-642025-02-11C16284748780-12cef2736-7a4c-d83d-e063-dadaa90ab31f726R Walgreens DM Mucus Fast Max Day Cold & Flu and Night Cold & Flu
0363-9617-642025-01-30C16284748780-12cef2736-7a4c-d83d-e063-dadaa90ab31f726R Walgreens DM Mucus Fast Max Day Cold & Flu and Night Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9617-64Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu4 in 1 CARTONKIT43
0363-9617-64Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu1 in 1 BLISTER PACKKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9617MUCUS DM FAST MAX DAY COLD AND FLU AND NIGHT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALGREENS]3Current NDC, 2 package rows20250213_f3770976-de73-52b8-e053-2995a90aad4f.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 59 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
application number: M012
SU PHEDRINE PE SINUS CONGESTIONPHENYLEPHRINE HCLSalado Sales, Inc.ba075ff7-4e26-4856-8335-0c7dd4e198ea2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCbab078bb-f6b0-4394-84de-92b2c582b5da2026-01-12WarningsExact identifier
application number: M012
Nasal Decongestant PE Non-Drowsy Maximum StrengthPHENYLEPHRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d2026-01-12WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
application number: M012
GUAIFENESIN 400MG CAPLETSGUAIFENESINGendose Pharmaceuticals, LLCe7b82ec7-ef23-50c1-e053-2a95a90a662f2026-01-10WarningsExact identifier
application number: M012
Daytime Cold and FluDAYTIME COLD AND FLUAllegiant Health69ed2da0-16b2-49eb-91b4-cc5cf328c8172026-01-09WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutionsa5809774-ed52-4f54-b48e-888631e0223d2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutions5767f546-a751-4583-a8b7-971175c27ef02026-01-09WarningsExact identifier
application number: M012
Thompson Cough and Cold Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,Thompsone77725b1-15da-35bd-e053-2a95a90ad6ba2026-01-08WarningsExact identifier
application number: M012
Mucosan Childrens Multi-Symptom GrapeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.266c8cce-cdf9-557d-e063-6394a90a9bc32026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom HoneyDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.2669c620-ab70-abaa-e063-6394a90a58e72026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom CherryDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26b8c06d-4a72-3979-e063-6394a90a96d72026-01-08WarningsExact identifier
application number: M012
Mucosan Max with AcetaminophenACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26a4861b-5d8e-9ec6-e063-6394a90af5772026-01-08WarningsExact identifier
application number: M012
Mucosan Severe Multi-SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.26a69342-f65f-cb46-e063-6394a90ade102026-01-08WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.e4e15c13-f583-4484-a5f0-f04c39c7b7c92026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non DrowsyASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a355d987-77ce-9e32-e053-2995a90a64312026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560237{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) } PackGPCKf3770976-de73-52b8-e053-2995a90aad4f3
25602371 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) PackPSNf3770976-de73-52b8-e053-2995a90aad4f3
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf3770976-de73-52b8-e053-2995a90aad4f3
2549037acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral TabletPSNf3770976-de73-52b8-e053-2995a90aad4f3
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf3770976-de73-52b8-e053-2995a90aad4f3
2549037acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCDf3770976-de73-52b8-e053-2995a90aad4f3
25602371 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) PackSYf3770976-de73-52b8-e053-2995a90aad4f3
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf3770976-de73-52b8-e053-2995a90aad4f3
2549037APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSYf3770976-de73-52b8-e053-2995a90aad4f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9617-64003639617644 BLISTER PACK in 1 CARTON (0363-9617-64) / 1 KIT in 1 BLISTER PACK * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK4 blister pack2024-12-23NoNoCurrent