FDA.reportPublic FDA data

NDC 50090-2301-01 - Mucinex Maximum Strength

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
50090-2301
Requested NDC
50090-2301-01
Package NDCs from labels
50090-2301-0, 50090-2301-1, 50090-2301-01
Manufacturer
A-S Medication Solutions
Effective date
2025-06-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mucinex Maximum Strength - A-S Medication SolutionsA-S Medication Solutions2025-06-09HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2301-02023-02-06C16284748780-1f386c649-eea7-0266-e053-dadaa90a7c1aMUCINEX MAXIMUM STRENGTH
50090-2301-02023-01-30C16284748780-1f386c649-eea7-0266-e053-dadaa90a7c1aMUCINEX MAXIMUM STRENGTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2301-0MucinexMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE117
50090-2301-0MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE717
50090-2301-1MucinexMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE217
50090-2301-1MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2301MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 4 package rows20231207_7e09314c-3421-4053-a2ac-b67bf5610f83.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2301-0EA - Each50090-2301c22da608-cd69-4237-961a-e2dd51db521412018-11-06
50090-2301-1EA - Each50090-230114b7662d-abc9-4b28-8fad-89170611143512025-09-12

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 7 of 71 · 1,407 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
unii: 495W7451VQ
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsExact identifier
rxcui: 310621
unii: 495W7451VQ
GuaifenesinGUAIFENESINAurohealth LLC062e3d83-8495-4c8f-b1e6-5eb37fd532242026-07-03WarningsExact identifier
rxcui: 310621
unii: 495W7451VQ
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
unii: 495W7451VQ
equate mucus-erGUAIFENESINWALMART INC.a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea32026-07-02WarningsExact identifier
unii: 495W7451VQ
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
unii: 495W7451VQ
Green Guard Instydose Mucus ReliefGUAIFENESINUnifirst First Aid Corporation5b21bd13-d649-6570-e063-6394a90a51e92026-07-01WarningsExact identifier
unii: 495W7451VQ
Medique Guaicon InsydoseGUAIFENESINUnifirst First Aid Corporation5b230d04-3cf2-51e0-e063-6294a90a24982026-07-01WarningsExact identifier
unii: 495W7451VQ
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINBryant Ranch Prepacka898b584-e17e-45c4-8a28-9f686b95dca02026-06-29WarningsExact identifier
application number: NDA021282
unii: 495W7451VQ
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLC259b6f12-50c0-4e7a-9a44-bdf7e9a20a562026-06-29WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINBryant Ranch Prepacka8c67e0a-1f2c-4e96-91fe-0d90546d8b1b2026-06-29WarningsExact identifier
application number: NDA021282
unii: 495W7451VQ
MUCUS RELIEF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdb57f6b3-30ca-4a65-9043-f61be24d9b502026-06-25WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINYYBA CORP4cb11551-31e3-5c01-e063-6394a90ab0d42026-06-25WarningsExact identifier
unii: 495W7451VQ
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEF - DM MAXIMUM STRENGTHGUAIFENESIN, DEXTROMETHORPHAN HBRYYBA CORP4f6da14e-f2ca-cb33-e063-6394a90a9ff82026-06-24WarningsExact identifier
unii: 495W7451VQ
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINYYBA Corp5074b172-311b-43e2-e063-6394a90aa70f2026-06-22WarningsExact identifier
rxcui: 310621
unii: 495W7451VQ
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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