FDA.reportPublic FDA data

Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz

Product NDC
52904-830
11-digit product format
529040830
Labeler code
52904
Product ID
52904-830_eda1d1c6-b5f4-4b40-89c5-ee0c44a78ee3
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Select Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-07-03
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52904-830IInactivated by FDA2026-10-05
excluded packagepackage52904-83052904-830-04IInactivated by FDA2026-10-05
excluded packagepackage52904-83052904-830-05IInactivated by FDA2026-10-05
excluded packagepackage52904-83052904-830-20IInactivated by FDA2026-10-05
excluded packagepackage52904-83052904-830-25IInactivated by FDA2026-10-05
excluded packagepackage52904-83052904-830-30IInactivated by FDA2026-10-05

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 2 · 90 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 packagepackage52904-830-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-830-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-830-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-830-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52904-830-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-830-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-830-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-830-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-830-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52904-830-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-830-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-830-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-830-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-830-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52904-830-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-830-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-830-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-830-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-830-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52904-830-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-830-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-830-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-830-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-830-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52904-830-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-830-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-830-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-830-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-830-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52904-830-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-830-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-830-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-830-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-830-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52904-830-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-830-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-830-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-830-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-830-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52904-830-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-830-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-830-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-830-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-830-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52904-830-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-830-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-830-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-830-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-830-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52904-830-30ad56d346431e…cc804d4bbf1e…

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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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
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
52904-830-04Alka Seltzer Plus ® Severe Cold and Flu
52904-830-05Alka Seltzer Plus ® Severe Cold and Flu
52904-830-20Alka Seltzer Plus ® Severe Cold and Flu
52904-830-25Alka Seltzer Plus ® Severe Cold and Flu
52904-830-30Alka Seltzer Plus ® Severe Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-830-04Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-04Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz1 in 1 BLISTER PACKTABLET, EFFERVESCENT12
52904-830-05Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 BLISTER PACKTABLET, EFFERVESCENT22
52904-830-05Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-20Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-20Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz20 in 1 CARTONTABLET, EFFERVESCENT202
52904-830-25Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
52904-830-25Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz25 in 1 CARTONTABLET, EFFERVESCENT252
52904-830-30Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz30 in 1 CARTONTABLET, EFFERVESCENT302
52904-830-30Alka Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-830ALKA SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, EFFERVESCENT) TABLET, EFFERVESCENT [SELECT CORPORATION]2Legacy NDC, 10 package rows20220514_00c4b91d-2edf-4090-9de3-7eac35d7428c.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 TabletPSN00c4b91d-2edf-4090-9de3-7eac35d7428c2
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCD00c4b91d-2edf-4090-9de3-7eac35d7428c2
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSY00c4b91d-2edf-4090-9de3-7eac35d7428c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-830-04529040830041 POUCH in 1 BLISTER PACK (52904-830-04) > 2 TABLET, EFFERVESCENT in 1 POUCH1 pouch2017-07-030000-00-00NoNoCurrent
52904-830-05529040830052 POUCH in 1 BLISTER PACK (52904-830-05) > 2 TABLET, EFFERVESCENT in 1 POUCH2 pouch2017-07-030000-00-00NoNoCurrent
52904-830-205290408302020 POUCH in 1 CARTON (52904-830-20) > 2 TABLET, EFFERVESCENT in 1 POUCH20 pouch2017-07-030000-00-00NoNoCurrent
52904-830-255290408302525 POUCH in 1 CARTON (52904-830-25) > 2 TABLET, EFFERVESCENT in 1 POUCH25 pouch2017-07-030000-00-00NoNoCurrent
52904-830-305290408303030 POUCH in 1 CARTON (52904-830-30) > 2 TABLET, EFFERVESCENT in 1 POUCH30 pouch2017-07-030000-00-00NoNoCurrent