FDA.reportPublic FDA data

Severe Congestion and Cough

Product NDC
55319-204
11-digit product format
553190204
Labeler code
55319
Product ID
55319-204_855c21ba-8243-43c4-8c75-b7cbff43159f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Family Dollar Services Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-04
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
Severe Congestion and Cough
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
b9215a5e-3be8-44fd-9189-50dab760869cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-204-45Severe Congestion and Cough177 mL in 1 BOTTLE, PLASTICSOLUTION1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-204SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [FAMILY DOLLAR SERVICES INC]3Current NDC, 1 package rows20250110_b9215a5e-3be8-44fd-9189-50dab760869c.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 31 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC09fdf96f-345f-43f2-9f0f-8303ac70849e2026-05-13WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc2ac53cc7-000f-41fd-b799-4e6d6886fe622026-05-13WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
application number: M012
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
application number: M012
Allergy Relief mini SoftgelsDIPHENHYDRAMINE HCI 25 MGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdf1c620b-ff59-4126-99a5-1d6750888f2b2026-05-12WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC14c56f3d-67fd-45ef-a16b-f276047228832026-05-12WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.51a4195b-8776-964c-e063-6294a90aa0752026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba3548e-85e7-b4a6-e063-6394a90af84d2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe7eeb71-e219-4c84-ac06-98c3a40b14dc2026-05-12WarningsExact identifier
application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51a45db8-2bee-6fd0-e063-6394a90ab5872026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC19da539e-7b57-41d7-aad5-fc89a6705e202026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8a790eeb-7d7d-4a94-9103-6ed09c04d5962026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCdbdafbb4-f3c9-4042-b867-db4d06dc3d612026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd03ef2fd-1a08-42c0-b69d-fd4e4285ccd32026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC29571047-4c4b-44ca-8726-57c28308e8cf2026-05-12WarningsExact identifier
application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCc746953f-4b7d-4e2a-9b85-96bd6901f5172026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2ef9d5de-e99e-4398-bf97-c7bef94498fa2026-05-12WarningsExact 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 SolutionPSNb9215a5e-3be8-44fd-9189-50dab760869c4
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDb9215a5e-3be8-44fd-9189-50dab760869c4
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYb9215a5e-3be8-44fd-9189-50dab760869c4
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYb9215a5e-3be8-44fd-9189-50dab760869c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-204-4555319020445177 mL in 1 BOTTLE, PLASTIC (55319-204-45) 177 ml2024-01-04NoNoCurrent