Alka-Seltzer Plus

Product NDC
0280-7055
11-digit product format
002807055
Labeler code
0280
Product ID
0280-7055_65ba586b-63c2-1dd9-e053-2991aa0a8179
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride
Dosage form
GRANULE, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-02
Marketing end
2020-11-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
250 mg/1; mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0280-7055DDiscontinued by firm2026-10-15
excluded packagepackage0280-70550280-7055-20DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0280-7055-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0280-7055-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0280-7055-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0280-7055-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0280-7055-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0280-7055-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0280-7055-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0280-7055-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0280-7055-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0280-7055-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0280-7055-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0280-7055-20557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
Chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9ZALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
AcetaminophenACTIVE MOIETY362O9ITL9DALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
ChlorpheniramineACTIVE MOIETY3U6IO1965UALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
DextromethorphanACTIVE MOIETY7355X3ROTSALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
PhenylephrineACTIVE MOIETY1WS297W6MVALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
Acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9ALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
aspartameINACTIVE INGREDIENTZ0H242BBR1ALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
mannitolINACTIVE INGREDIENT3OWL53L36AALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TYALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOALKA-SELTZER PLUS SEVERE COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, EFFERVESCENT [BAYER HEALTHCARE LLC - CONSUMER CARE]1