FDA.reportPublic FDA data

Alka-Seltzer Plus Severe Sinus Cold and Cough

Product NDC
0280-0507
11-digit product format
002800507
Labeler code
0280
Product ID
0280-0507_452662db-192f-a610-e063-6394a90a4a10
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-28
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 Sinus Cold and Cough
Brand name suffix
Liquid Gels
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
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
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
0dba1329-5b0d-5688-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
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c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0507-20Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels2 in 1 CARTONCAPSULE, LIQUID FILLED28
0280-0507-20Alka-Seltzer Plus Severe Sinus Cold and CoughLiquid Gels20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0507-20EA - Each0280-050799c5c10e-b66c-485b-a516-479f2e13041212019-09-05

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0507ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 2 package rows20231205_0dba1329-5b0d-5688-e054-00144ff8d46c.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 28 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTH, TRAVEL BASIXACETAMINOPHENLil' Drug Store Products, Inc.fa951d50-b79c-4161-8c81-fcf386b0964e2025-12-15WarningsExact identifier
application number: M013
Vanquish Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEDSE Healthcare Solutions, LLCcbf12223-ef44-494b-9d3c-971dce3c5ade2025-12-15WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8bc75bcf-01c9-41d0-a96f-77a24e3edf012025-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS40a1b354-9b2e-1cf3-e063-6394a90af1132025-12-13WarningsExact identifier
application number: M013
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
application number: M013
Pain Reliever, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN TABLETLil' Drug Store Products, Inc.45c397bd-a1ff-1246-e063-6394a90ac54a2025-12-12WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c7c11b-d627-aee8-e063-6294a90a401d2025-12-12WarningsExact identifier
application number: M013
AspirinASPIRINTOP CARE (Topco Associates LLC)d3df90be-9037-44b2-bf48-540d68a033b22025-12-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINHy-Vee98ab6fb7-c7e5-45ab-97c3-81d422f8a8432025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma33599f18-5f49-4f22-8a77-a072115763ef2025-12-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINVALU MERCHANDISERS COMPANY746059b3-ed18-4a81-a70e-4d758e048d8e2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY005e299e-aa84-49d9-bbca-12236f865a272025-12-11WarningsExact identifier
application number: M013
Low Dose Chewable AspirinASPIRINVALU MERCHANDISERS COMPANY7d88f156-d361-4249-b70d-4bbcd5ba30b72025-12-11WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINVALU MERCHANDISERS COMPANYcc18e8e1-652e-44da-a9d7-e56cebda55a12025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYd4c32e70-778a-4d66-b9d0-03944a5284212025-12-11WarningsExact identifier
application number: M013
adult low dose aspirinASPIRINVALU MERCHANDISERS COMPANY6fa1c707-bd42-455b-90a3-2c2a11acc6832025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY5a80cb17-7731-4457-acd3-64cf4accf8622025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENVALU MERCHANDISERS COMPANY02e3798f-86d9-64b4-e063-6294a90a29de2025-12-11WarningsExact identifier
application number: M013

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 CapsulePSN0dba1329-5b0d-5688-e054-00144ff8d46c8
1432488acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD0dba1329-5b0d-5688-e054-00144ff8d46c8
1432488APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY0dba1329-5b0d-5688-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0507-20002800507202 BLISTER PACK in 1 CARTON (0280-0507-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2015-01-280000-00-00NoNoCurrent