FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
83324-323
11-digit product format
833240323
Labeler code
83324
Product ID
83324-323_4b7f60a9-2707-4177-9fd1-34063642ff5b
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-15
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
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-323-06Mucus Relief DM177 mL in 1 BOTTLE, PLASTICSOLUTION1772

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 76 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Cherry Cough DropsMENTHOLGeiss, Destin, Dunnc72db7f0-9324-8ed2-e053-2995a90a98682025-12-12WarningsExact identifier
application number: M012
Good Sense Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunnc72e557f-0211-81b9-e053-2995a90a14372025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Benzocaine LozengesBENZOCAINEGeiss, Destin, Dunnc7404c94-09eb-5cc5-e053-2995a90af0212025-12-12WarningsExact identifier
application number: M012
Good Sense SF Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunne11ed21f-6ceb-5908-e053-2995a90aea462025-12-12WarningsExact identifier
application number: M012
Severe Congestion Relief Maximum Strength SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inc59918b8b-5c91-468f-834e-66020dc1ae122025-12-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLSALADO SALES INC.8f66f5bc-7c77-420b-9feb-911c980fbfdc2025-12-12WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.de55a9fd-53a2-4f3e-82b7-cabcbe287d462025-12-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESALADO SALES INC.cc73b668-cc6a-41d6-800a-4988c59c04492025-12-12WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC75269bcc-3bb2-49a0-8788-6b7da18796d32025-12-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus plus AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEaffac07f-d645-4999-98ee-7467902f5adc2025-12-12WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCf7e925f4-7da6-4157-a97f-e6a3e399911f2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH645f8075-e33f-4e1a-9249-7368261cdcb92025-12-11WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp8fd0071b-c6ca-49e6-b159-45dead71b6642025-12-11WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp098582dc-3e12-782f-e063-6394a90aa1a12025-12-11WarningsExact identifier
application number: M012
GUAIASORB DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp09866b9c-aa32-45eb-e063-6394a90a49032025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd6947661-a6dd-4bc4-a0ca-932db1840f582025-12-11WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY2e751d67-51b4-4b74-a9e8-7f3bc56369842025-12-11WarningsExact identifier
application number: M012
Pressure and Pain Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY232acb86-7383-4992-b333-1e47bf7c06ad2025-12-11WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY72847721-9f59-4af1-8f20-dc84497429182025-12-11WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401317-0295-14b3-e053-2a95a90acbb42025-12-11WarningsExact 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 SolutionPSNd02f32c1-716e-4753-abba-ff97c4dc9e222
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd02f32c1-716e-4753-abba-ff97c4dc9e222
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYd02f32c1-716e-4753-abba-ff97c4dc9e222
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd02f32c1-716e-4753-abba-ff97c4dc9e222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-323-0683324032306177 mL in 1 BOTTLE, PLASTIC (83324-323-06) 177 ml2025-09-15NoNoCurrent