FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
67091-342
11-digit product format
670910342
Labeler code
67091
Product ID
67091-342_5d6beb4c-031a-4fce-8627-00205c2c1680
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
WINCO FOODS, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-16
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Mucus Relief DM
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6afa830-6ce2-4abc-b5c9-3f5f156444dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-342-06Mucus Relief DMMaximum Strength180 mL in 1 BOTTLESOLUTION1808

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-342MUCUS RELIEF DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SOLUTION [WINCO FOODS, LLC]7Current NDC, Legacy NDC, 1 package rows20241121_e6afa830-6ce2-4abc-b5c9-3f5f156444df.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 90 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC15b3de6c-7ccc-408b-8789-d0e2f21a88352025-11-12WarningsExact identifier
application number: M012
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
application number: M012
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
application number: M012
DESGEN DMDEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCLKramer Novis6ab47174-e1fd-47ce-8788-06b7cdad52182025-11-12WarningsExact identifier
application number: M012
PresgenGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novisedad7a86-0d27-4a98-85b2-4b6725904f282025-11-12WarningsExact identifier
application number: M012
TUSSI PRES PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVISb01a45df-3cea-4729-80c1-7f35b7f707f02025-11-12WarningsExact identifier
application number: M012
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
application number: M012
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
application number: M012
TOPCARE Childrens Cold and Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDETopco Associates, LLC8931d4ca-c599-49be-87e1-8c0598f38b772025-11-11WarningsExact identifier
application number: M012
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNe6afa830-6ce2-4abc-b5c9-3f5f156444df8
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe6afa830-6ce2-4abc-b5c9-3f5f156444df8
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYe6afa830-6ce2-4abc-b5c9-3f5f156444df8
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe6afa830-6ce2-4abc-b5c9-3f5f156444df8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-342-0667091034206180 mL in 1 BOTTLE (67091-342-06) 180 ml2019-07-160000-00-00NoNoCurrent