ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night

Product NDC
0280-8284
11-digit product format
002808284
Labeler code
0280
Product ID
0280-8284_53715ea4-42b4-5887-e063-6294a90a4249
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate
Dosage form
KIT
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
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
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1534835Internal RxNorm lookup
1550968Internal RxNorm lookup
1804384Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53715ea4-42b3-5887-e063-6294a90a4249Available on FDA.report

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 59 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapo SteamVAPO STEAMTOPCO ASSOCIATES, LLCf216f69f-9580-25ac-e053-2995a90a5ac62026-01-14WarningsExact identifier
application number: M012
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
application number: M012
Sinus PE plus AllergyCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLWalgreen Companya15979d4-87bf-42e7-b1f2-7834960721412026-01-13WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.4260542e-0980-4b0b-8177-1c9f2c53b5a62026-01-13WarningsExact identifier
application number: M012
Sweet ComfortMENTHOLSaje Natural Business Inc.cf13cccd-723d-4d61-8a5e-b36281605cc72026-01-13WarningsExact identifier
application number: M012
FortifyMENTHOLSaje Natural Business Inc.0320a305-99d1-4909-94cc-cd6509ecb9482026-01-13WarningsExact identifier
application number: M012
Rolling FarmacyMENTHOLSaje Natural Business Inc.a38765a9-22cd-4fc5-b5ab-c3cacbd52c742026-01-13WarningsExact identifier
application number: M012
Home FarmacyMENTHOLSaje Natural Business Inc.add35d10-b27a-4ae8-b2de-8a285aaef1552026-01-13WarningsExact identifier
application number: M012
Traveling FarmacyMENTHOLSaje Natural Business Inc.5b70f5aa-ed36-65ab-e053-2a91aa0a67772026-01-13WarningsExact identifier
application number: M012
sinus plus allergy PE maximum strengthCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI660d3c80-f249-41dd-aa93-a0b1e635ead02026-01-13WarningsExact identifier
application number: M012
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLH E Bc9e977b6-fba6-49ea-9d80-b43b0842bbe12026-01-12WarningsExact identifier
application number: M012
PE Sinus CongestionPHENYLEPHRINE HCLTopco Associates, LLC3264e291-7a0f-4e25-8390-ba441f22f6502026-01-12WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACY3f44cff6-240a-4a8d-aaa1-0da75a31a47b2026-01-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus Congestion Non-DrowsyPHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEb9122fd0-0bed-4302-9bbe-cd6a46d298182026-01-12WarningsExact identifier
application number: M012
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
application number: M012
SU PHEDRINE PE SINUS CONGESTIONPHENYLEPHRINE HCLSalado Sales, Inc.ba075ff7-4e26-4856-8335-0c7dd4e198ea2026-01-12WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-8284-12002808284121 KIT in 1 CARTON (0280-8284-12) * 1 POWDER, FOR SOLUTION in 1 PACKET * 1 POWDER, FOR SOLUTION in 1 PACKET1 kit2026-06-01NoNoCurrent