FDA.reportPublic FDA data

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 110 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
application number: M012
leader childrens allergy reliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. dba Leader40d697b7-dc59-4d24-8d46-db635e01b9d52025-07-22WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEChain Drug Consortium34005c55-3176-4f28-9a3b-7dc6fefd01fe2025-07-19WarningsExact identifier
application number: M012
Sinus Relief Daytime NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company73a77a13-983b-4e65-bb3c-2ba5e9f33a3e2025-07-19WarningsExact identifier
application number: M012
QUALITY CHOICE No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)7cb6ad04-7847-46b9-b371-0a3473001c792025-07-18WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLChain Drug Consortium270e9221-d305-4148-b523-741e02fe733f2025-07-18WarningsExact identifier
application number: M012
ACTISPEC PSEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC5def1555-87f4-41d5-8a5c-be560aa8f1e22025-07-17WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAYACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1a17b24a-8022-4e2f-e063-6294a90af2762025-07-17WarningsExact identifier
application number: M012
BULPOL Smoking PatchesMENTHOLJiashen International Trade Limited3a1cc0e1-fabf-52b9-e063-6394a90ae35e2025-07-17WarningsExact identifier
application number: M012
Ampigrin Ultra Forte NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e71c3-fe7c-77c7-e053-2995a90a34b22025-07-17WarningsExact identifier
application number: M012
NitecinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCdfb56532-6f72-1e4d-e053-2a95a90a1c052025-07-17WarningsExact identifier
application number: M012
tabcin NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLC0b3ed2bb-88ed-699e-e063-6394a90ac0232025-07-17WarningsExact 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