Alka-Seltzer Plus Severe Cough Mucus and Congestion

Product NDC
0280-0505
Requested package NDC
0280-0505-20
11-digit product format
002800505
Labeler code
0280
Product ID
0280-0505_45266194-8eb1-21f4-e063-6294a90af1dc
Type
HUMAN OTC DRUG
Nonproprietary name
Alka-Seltzer Plus Severe Cough Mucus and Congestion
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-07
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
250; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
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
2026-12-31
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
Alka-Seltzer Plus Severe Cough Mucus and Congestion
Brand name suffix
Liquid Gels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
ACETAMINOPHEN250 mg/1
GUAIFENESIN200 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1432488Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c120569-622d-3a23-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0505-20Alka-Seltzer Plus Severe Cough Mucus and CongestionLiquid Gels2 in 1 CARTONCAPSULE, LIQUID FILLED28
0280-0505-20Alka-Seltzer Plus Severe Cough Mucus and CongestionLiquid Gels20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0505-20EA - Each0280-05058ea7a7fc-a2ac-494d-b781-d53a2a33533b12019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
GUAIFENESINACTIVE INGREDIENT495W7451VQALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
GUAIFENESINACTIVE MOIETY495W7451VQALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
GELATININACTIVE INGREDIENT2G86QN327LALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SHELLACINACTIVE INGREDIENT46N107B71OALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SORBITOLINACTIVE INGREDIENT506T60A25RALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
WATERINACTIVE INGREDIENT059QF0KO0RALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0505ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 2 package rows20231205_0c120569-622d-3a23-e054-00144ff88e88.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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1432488acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN0c120569-622d-3a23-e054-00144ff88e888
1432488acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD0c120569-622d-3a23-e054-00144ff88e888
1432488APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY0c120569-622d-3a23-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0505-20002800505202 BLISTER PACK in 1 CARTON (0280-0505-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2015-01-070000-00-00NoNoCurrent