Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy
- Product NDC
- 0280-0024
- 11-digit product format
- 002800024
- Labeler code
- 0280
- Product ID
- 0280-0024_47e317c2-ea4e-8cce-e063-6394a90a9182
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- asprin, 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
- ASPIRIN; PHENYLEPHRINE BITARTRATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 7.8; 10 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], 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
- 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 Plus Severe Cold PowerFast Fizz Non Drowsy
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 325 mg/1 |
| PHENYLEPHRINE BITARTRATE | 7.8 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
| 27O3Q5ML57 | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1536498 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a355d987-77ce-9e32-e053-2995a90a6431 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0024-01 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 5 | |
| 0280-0024-01 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 5 | |
| 0280-0024-02 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 5 | |
| 0280-0024-02 | Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0024 | ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY (ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231212_a355d987-77ce-9e32-e053-2995a90a6431.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2664074 | {1 (aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) } Pack | GPCK | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 2664074 | 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack | PSN | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 1537029 | aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 1537029 | aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 2664074 | 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack | SY | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 1537029 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | fc60af2f-83cb-99ea-e053-6394a90a0b3b | 13 |
| 2565492 | {1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) } Pack | GPCK | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 2565492 | 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack | PSN | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 2565491 | aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | a355d987-77ce-9e32-e053-2995a90a6431 | 5 |
| 2565491 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | a355d987-77ce-9e32-e053-2995a90a6431 | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 2565492 | 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack | SY | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 2565491 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | c2232241-6e57-1427-e053-2995a90a488a | 5 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | a355d987-77ce-9e32-e053-2995a90a6431 | 5 |
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 50738a43-7299-270c-e063-6294a90af2cc | 1 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 50738a43-7299-270c-e063-6294a90af2cc | 1 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 50738a43-7299-270c-e063-6294a90af2cc | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0024-01 | 00280002401 | 10 POUCH in 1 CARTON (0280-0024-01) / 2 TABLET, EFFERVESCENT in 1 POUCH | 10 pouch | 2020-04-30 | 0000-00-00 | No | No | Current |
| 0280-0024-02 | 00280002402 | 24 POUCH in 1 CARTON (0280-0024-02) / 2 TABLET, EFFERVESCENT in 1 POUCH | 24 pouch | 2022-07-01 | 0000-00-00 | No | No | Current |