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 9 of 70 · 1,388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex 12HR Cold and Fever Multi-SymptomNAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC49f1f415-8017-0974-e063-6294a90a89182026-06-02WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
unii: 495W7451VQ
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.53371691-2510-5039-e063-6394a90a6ea92026-06-01WarningsExact identifier
unii: 495W7451VQ
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
unii: 495W7451VQ
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
unii: 495W7451VQ
mucus relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation84b5d83d-aea5-42ed-b20c-96d3b389c8c02026-05-27WarningsExact identifier
unii: 495W7451VQ
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex Maximum StrengthGUAIFENESINReckitt Benckiser LLC47f5323c-ee3a-400d-b133-31d9c286fafd2026-05-27WarningsExact identifier
application number: NDA021282
ndc (product): 63824-023
rxcui: 891297
rxcui: 310621
spl id: 52d0f6be-a3c0-c950-e063-6294a90a5784
spl set id: 47f5323c-ee3a-400d-b133-31d9c286fafd
unii: 495W7451VQ
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
application number: NDA021282
unii: 495W7451VQ
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
unii: 495W7451VQ
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
unii: 495W7451VQ
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
unii: 495W7451VQ
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
unii: 495W7451VQ
Leader Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader12971fb2-2314-4443-bf70-b7eb5859b1482026-05-26WarningsExact identifier
unii: 495W7451VQ
equate mucus reliefGUAIFENESINWALMART INC.154602ca-91c4-4030-ae77-9bf179cc95e82026-05-26WarningsExact identifier
rxcui: 310621
unii: 495W7451VQ
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsc04e67da-51f6-4ce3-9852-419d7b3a37422026-05-22WarningsExact identifier
unii: 495W7451VQ
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
unii: 495W7451VQ
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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