Mucus Relief Severe Congestion and Cough

Product NDC
41163-047
11-digit product format
411630047
Labeler code
41163
Product ID
41163-047_4fe1d5c0-d05c-4834-9cbb-f3232377aa49
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 Severe Congestion and Cough
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043543Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdf63308-fe7b-4613-a012-ed5e4c9f8ffeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-047-06Mucus Relief Severe Congestion and CoughMaximum Strength177 mL in 1 BOTTLE, PLASTICLIQUID1776

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
SORBITOLINACTIVE INGREDIENT506T60A25RMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
WATERINACTIVE INGREDIENT059QF0KO0RMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EQUALINE (SUPERVALU)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-047MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 1 package rows20240524_fdf63308-fe7b-4613-a012-ed5e4c9f8ffe.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 8 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus PE Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLC28a4ec37-11dd-4134-81aa-851f081bf0882026-08-17WarningsExact identifier
application number: M012
CVS Health No DripNASAL MISTCVS PHARMACY,INC.60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa2026-08-17WarningsExact identifier
application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion ChildrensBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreens2bdc62b6-f3e1-4a79-9b29-00cc1d4280b32026-08-17WarningsExact identifier
application number: M012
CVS Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS HEALTHf01ab8ef-d29a-4e33-8a14-4c57ccdcc0d62026-08-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLKROGER COMPANY30d50bbe-0a14-c985-e063-6294a90a47b32026-08-16WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE77f87e19-a9d5-479d-9434-bbde13210bfb2026-08-15WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leaderb1c2055b-4b5a-4fa2-b600-8930c9c8524c2026-08-15WarningsExact identifier
application number: M012
Nighttime HBP Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY146c9a62-0418-4b5d-9074-5be8a05f3f932026-08-15WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
Nasal Decongestant Maximum Strength, Non-DrowsyPSEUDOEPHEDRINE HCLAmerisource Bergen1fdb1ba5-4072-4baf-9e30-f01d57bf6d822026-08-15WarningsExact identifier
application number: M012
Cold and Flu NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Company32c67914-d7cf-40ee-8682-0ba8ed6912872026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCe7c8ffed-83b8-4088-b72c-d937e93f8b542026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNfdf63308-fe7b-4613-a012-ed5e4c9f8ffe6
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDfdf63308-fe7b-4613-a012-ed5e4c9f8ffe6
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYfdf63308-fe7b-4613-a012-ed5e4c9f8ffe6
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYfdf63308-fe7b-4613-a012-ed5e4c9f8ffe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-047-0641163004706177 mL in 1 BOTTLE, PLASTIC (41163-047-06) 177 ml2014-11-300000-00-00NoNoCurrent