FDA.reportPublic FDA data

Alka-Seltzer Plus Cold Day and Night PowerMax gels

Product NDC
0280-0099
11-digit product format
002800099
Labeler code
0280
Product ID
0280-0099_452656ff-79e2-0871-e063-6294a90ac49d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine bitartrate, Doxylamine succinate
Dosage form
KIT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-01
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 Cold Day and Night PowerMax gels
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup
1297288Internal RxNorm lookup
2634363Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6c73f61-f4fc-377f-e053-6294a90a3797Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0099-01Alka-Seltzer Plus Cold Day and Night PowerMax gels1 in 1 CARTONKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0099ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE LLC.]10Current NDC, 1 package rows20240821_f6c73f61-f4fc-377f-e053-6294a90a3797.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 100 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freegells Cough Drops Menthol 80ctMENTHOLRL Albert & Son Inc.c96cc162-5908-4990-9dc1-3ce9128442742025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLR.L. ALBERT & SON, INCbac77712-6197-4b30-a5f8-9b99eb9d7b5a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLR.L. ALBERT & SON, INC6842d766-ade6-40b2-831b-f4feac25c6db2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLRL Albert & Son Inc.9f324ca1-0e2a-47e3-997e-2aaa68a857512025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INC2063a013-aa0b-465d-b04f-cfe2e70d749f2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 200ctMENTHOLR.L. ALBERT & SON, INCcd81488c-74d8-48d9-9c73-ff662a5cd4cd2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPSMENTHOLR.L. ALBERT & SON, INCc6b36350-386b-4346-bef0-a37ec11319c02025-10-08WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC3314b174-d5bb-4843-9288-9b9c5fce79d52025-10-08WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy22f55699-4922-4c05-bdf5-5844c7dd3ee52025-10-07WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral SolutionDIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.407b7cbb-7ebd-7b7e-e063-6394a90af5012025-10-06WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc2025-10-06WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC2b19fdd2-8088-47f2-be20-f220a6b825fc2025-10-06WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
application number: M012
Giltuss DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc3f64c81a-bbfc-4575-e063-6294a90a6ed72025-10-06WarningsExact identifier
application number: M012
TexaClear Severe Cough, Cold and FluCHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGM Pharmaceuticals, INCcb99e5b3-1908-43c9-b31f-d35e7ce58b442025-10-06WarningsExact identifier
application number: M012
RoboHBr Cough SUPPRESSANTDEXTROMETHORPHAN HBRDXM Pharmaceutical, Inc0af624ce-191f-45e1-882b-e8acb90cc77b2025-10-06WarningsExact identifier
application number: M012
RoboTabletsDEXTROMETHORPHANDXM Pharmaceutical, Incb92cf698-032d-4d8d-b19c-456c6338b0942025-10-06WarningsExact identifier
application number: M012
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
application number: M012
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634363{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKf6c73f61-f4fc-377f-e053-6294a90a379711
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNf6c73f61-f4fc-377f-e053-6294a90a379711
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNf6c73f61-f4fc-377f-e053-6294a90a379711
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNf6c73f61-f4fc-377f-e053-6294a90a379711
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf6c73f61-f4fc-377f-e053-6294a90a379711
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf6c73f61-f4fc-377f-e053-6294a90a379711
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYf6c73f61-f4fc-377f-e053-6294a90a379711
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYf6c73f61-f4fc-377f-e053-6294a90a379711
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYf6c73f61-f4fc-377f-e053-6294a90a379711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-0099-01002800099011 KIT in 1 CARTON (0280-0099-01) * 2 CAPSULE in 1 BLISTER PACK / 8 CAPSULE, LIQUID FILLED in 1 CAPSULE * 2 CAPSULE in 1 BLISTER PACK / 4 CAPSULE, LIQUID FILLED in 1 CAPSULE1 kit2018-09-14NoNoCurrent