FDA.reportPublic FDA data

NDC 85237-1650-2 - Mucinex DM

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
85237-1650
Requested NDC
85237-1650-2
Package NDCs from labels
85237-1650-1, 85237-1650-3, 85237-1650-2
Manufacturer
Select Consumer Group
Effective date
2026-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mucinex DM - Select Consumer GroupSelect Consumer Group2026-08-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85237-1650-1Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE22
85237-1650-2Mucinex DM1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
85237-1650-2Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE22

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 71 of 118 · 2,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company0cc66c6c-db26-4bb2-a97d-c4106210d70c2025-06-10WarningsExact identifier
unii: 9D2RTI9KYH
Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.75a9c736-bc7e-4b7f-84ea-9474a37508ec2025-06-10WarningsExact identifier
unii: 9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucinex Maximum StrengthGUAIFENESINA-S Medication Solutions7e09314c-3421-4053-a2ac-b67bf5610f832025-06-09WarningsExact identifier
unii: 495W7451VQ
Equate Kids Daytime Dex Cough GelsDEXTROMETHORPHANWalmart37269cd6-1528-9879-e063-6394a90a2b542025-06-09WarningsExact identifier
unii: 9D2RTI9KYH
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
unii: 9D2RTI9KYH
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC2a29f0ed-d86b-4787-84e0-f7a8c5e7581f2025-06-09WarningsExact identifier
unii: 9D2RTI9KYH
DG health mucus er maxGUAIFENESINDolgencorp Inc4353d561-0e6d-4d36-b356-dd6506b5a3ee2025-06-06WarningsExact identifier
unii: 495W7451VQ
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp7e2fb43c-a7f1-4c1d-a700-7c6510999c032025-06-05WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact identifier
unii: 9D2RTI9KYH
Mucus ReliefGUAIFENESINBryant Ranch Prepackc648e711-e944-4574-83b3-ccce8732384e2025-06-02WarningsExact identifier
unii: 495W7451VQ
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Promethazine DMPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPAI Holdings, LLC dba PAI Pharma1d47280d-28c9-4701-8c5f-a6e6b524083b2025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Topcare Mucus ERGUAIFENESINTopco Associates LLCb787eac7-8f87-49a2-899b-5f524eb7b1fc2025-05-29WarningsExact identifier
unii: 495W7451VQ
Guaifenesin Extended-ReleaseGUAIFENESINPrecision Dose Inc.608b00c5-a2c7-4514-9b46-02954d6675d62025-05-27WarningsExact identifier
unii: 495W7451VQ
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus ReliefGUAIFENESINMeijer2d7aa3c1-5a4f-7197-e063-6394a90aff472025-05-21WarningsExact identifier
unii: 495W7451VQ
Guaifenesin Extended ReleaseGUAIFENESINPUBLIX SUPER MARKETS, INC038e1801-b978-4a2e-ae8c-8803596ec09c2025-05-20WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINPublix Super Markets, Inc435e627c-b4f4-4214-904a-7527aab32cbf2025-05-20WarningsExact identifier
unii: 495W7451VQ
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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