Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
- Product NDC
- 0280-0023
- 11-digit product format
- 002800023
- Labeler code
- 0280
- Product ID
- 0280-0023_4523854a-cb4c-04b8-e063-6294a90a5c88
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
- Dosage form
- TABLET, EFFERVESCENT
- Route
- ORAL
- Labeler
- Bayer Healthcare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-04-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
- Active strength
- 10; 325; 2; 7.8 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [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
- 2026-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0280-0023 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 0280-0023 | 0280-0023-01 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 0280-0023 | 0280-0023-02 | D | Discontinued by firm | 2026-10-12 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0280-0023-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0280-0023-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0280-0023-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0280-0023-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0280-0023-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0280-0023-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0280-0023-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0280-0023-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0280-0023-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0280-0023-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0280-0023-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0280-0023-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0280-0023-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0280-0023-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0280-0023-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0280-0023-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0280-0023-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0280-0023-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0280-0023-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0280-0023-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0280-0023-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0280-0023-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0280-0023-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0280-0023-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 Severe Cold and Cough PowerFast Fizz
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| ASPIRIN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE BITARTRATE | 7.8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| R16CO5Y76E | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 27O3Q5ML57 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1537029 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0023-01 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 13 | |
| 0280-0023-01 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 13 | |
| 0280-0023-02 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 13 | |
| 0280-0023-02 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 13 | |
| 0280-0023-03 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 13 | |
| 0280-0023-03 | Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0023 | ALKA-SELTZER PLUS SEVERE COLD AND COUGH POWERFAST FIZZ (ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] | 12 | Current NDC, Legacy NDC, 6 package rows | 20241208_dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | NASAL MIST | CVS PHARMACY,INC. | 60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa | 2026-08-17 | Warnings | M012 |
| Daytime Cold and Cough and NightTime Cold and Congestion Childrens | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | 2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3 | 2026-08-17 | Warnings | M012 |
| CVS Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS HEALTH | f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6 | 2026-08-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | KROGER COMPANY | 30d50bbe-0a14-c985-e063-6294a90a47b3 | 2026-08-16 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 77f87e19-a9d5-479d-9434-bbde13210bfb | 2026-08-15 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | M012 |
| Nighttime HBP Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY | 146c9a62-0418-4b5d-9074-5be8a05f3f93 | 2026-08-15 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | M012 |
| Nasal Decongestant Maximum Strength, Non-Drowsy | PSEUDOEPHEDRINE HCL | Amerisource Bergen | 1fdb1ba5-4072-4baf-9e30-f01d57bf6d82 | 2026-08-15 | Warnings | M012 |
| Cold and Flu Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | 32c67914-d7cf-40ee-8682-0ba8ed691287 | 2026-08-15 | Warnings | M012 |
| CVS Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY | 27820bce-6638-4f17-ac66-62b02b76bec3 | 2026-08-14 | Warnings | M012 |
| CVS PHARMACY Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE | CVS PHARMACY, INC. | 004e104b-d6ff-48d5-8685-cd1bff45399a | 2026-08-14 | Warnings | M012 |
| CHILDRENS DIMETAPP COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY | 7babf4f6-ca0a-44a7-b1ea-d60e20d36f15 | 2026-08-14 | Warnings | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | e7c8ffed-83b8-4088-b72c-d937e93f8b54 | 2026-08-14 | Warnings | M012 |
| CVS Mucus Relief DM and Overnight Cold and Flu | DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL | CVS | 75520b77-d40b-4f43-b92a-7a3eba5b493f | 2026-08-14 | Warnings | M012 |
| CVS Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | bb24c298-1d00-4378-8de3-b4056220fa75 | 2026-08-14 | Warnings | M012 |
| SEVERE COLD PLUS FLU DAYTIME NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS Pharmacy,Inc. | 6cb1d08b-e544-4084-b9ed-1e0d99a709c8 | 2026-08-14 | Warnings, Adverse reactions | M012 |
| Theraflu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 932a3d40-9b52-4e91-bc61-6fd506f2d9e6 | 2026-08-14 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy,Inc. | 91063edd-1e7e-41e9-8412-b14ef3749018 | 2026-08-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1537029 | aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 13 |
| 1537029 | aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 13 |
| 1537029 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0023-01 | 00280002301 | 10 POUCH in 1 CARTON (0280-0023-01) / 2 TABLET, EFFERVESCENT in 1 POUCH | 10 pouch | 2020-04-01 | 0000-00-00 | No | No | Current |
| 0280-0023-02 | 00280002302 | 24 POUCH in 1 CARTON (0280-0023-02) / 2 TABLET, EFFERVESCENT in 1 POUCH | 24 pouch | 2022-03-09 | 0000-00-00 | No | No | Current |
| 0280-0023-03 | 00280002303 | 12 POUCH in 1 CARTON (0280-0023-03) / 2 TABLET, EFFERVESCENT in 1 POUCH | 12 pouch | 2023-03-30 | No | No | Current |