FDA.reportPublic FDA data

Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz

Product NDC
0280-0022
Requested package NDC
0280-0022-02
11-digit product format
002800022
Labeler code
0280
Product ID
0280-0022_dd7d99ad-78f4-63ca-e053-2995a90aa890
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
250 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
2023-12-31
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 packagepackage0280-00220280-0022-02DDiscontinued by firm2026-10-12
excluded packagepackage0280-00220280-0022-02DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
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bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0022-01Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz10 in 1 CARTONTABLET, EFFERVESCENT1013
0280-0022-01Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT213
0280-0022-02Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT213
0280-0022-02Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz36 in 1 CARTONTABLET, EFFERVESCENT3613
0280-0022-03Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz1 in 1 BOXTABLET, EFFERVESCENT113
0280-0022-03Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz3200 in 1 BOXTABLET, EFFERVESCENT320013
0280-0022-04Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz24 in 1 CARTONTABLET, EFFERVESCENT2413
0280-0022-04Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT213
0280-0022-05Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz12 in 1 CARTONTABLET, EFFERVESCENT1213
0280-0022-05Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0022ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.]12Legacy NDC, 10 package rows20240816_dd7da15a-4e0b-405f-e053-2995a90a06d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSNd786ae07-ce57-44c7-9ba5-f4c87df115de4
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCDd786ae07-ce57-44c7-9ba5-f4c87df115de4
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSYd786ae07-ce57-44c7-9ba5-f4c87df115de4
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSN00c4b91d-2edf-4090-9de3-7eac35d7428c2
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSNf6068011-ad56-59b4-e053-2995a90ac0162
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCD00c4b91d-2edf-4090-9de3-7eac35d7428c2
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCDf6068011-ad56-59b4-e053-2995a90ac0162
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSY00c4b91d-2edf-4090-9de3-7eac35d7428c2
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSYf6068011-ad56-59b4-e053-2995a90ac0162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0022-020028000220236 POUCH in 1 CARTON (0280-0022-02) > 2 TABLET, EFFERVESCENT in 1 POUCH36 pouch2021-09-150000-00-00NoNoCurrent