Alka-Seltzer Plus Day Severe Cold Plus Flu
- Product NDC
- 0280-0921
- 11-digit product format
- 002800921
- Labeler code
- 0280
- Product ID
- 0280-0921_47e32f69-3232-a960-e063-6394a90a8590
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-04-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 500; 20; 400; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
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 package | package | 0280-0921 | 0280-0921-06 | D | Discontinued by firm | 2026-10-23 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 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 Day Severe Cold Plus Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 400 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1550968 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cec51eab-cce3-4965-a14e-a46d953050c4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0921-06 | Alka-Seltzer Plus Day Severe Cold Plus Flu | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 11 | |
| 0280-0921-06 | Alka-Seltzer Plus Day Severe Cold Plus Flu | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0921-06 | EA - Each | 0280-0921 | ebaf37ed-0c60-442b-bf4a-ddc1ebda33f1 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0921 | ALKA-SELTZER PLUS DAY SEVERE COLD PLUS FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240111_cec51eab-cce3-4965-a14e-a46d953050c4.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 |
|---|---|---|---|---|---|---|
| S2 | RACEPINEPHRINE HYDROCHLORIDE | Nephron Pharmaceuticals Corporation | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 2026-01-26 | Warnings | M012 |
| SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d97c634-0975-42d5-8ade-2ed2018cfe9d | 2026-01-26 | Warnings | M012 |
| GOOD SENSE NIGHT TIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | L. Perrigo Company | cd68289b-3850-40c6-9439-aae0e2d7637d | 2026-01-26 | Warnings | M012 |
| Seacall Nasal Spray. | NASAL SPRAY | Guangdong Quadrant Ecological Technology Co., Ltd. | 1f12618b-7461-fb47-e063-6294a90af753 | 2026-01-23 | Warnings | M012 |
| daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ecf7d210-102c-4053-81f6-67116de6cf7b | 2026-01-23 | Warnings | M012 |
| Good Neighbor Pharmacy Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | 44f9255b-0bf9-4573-ac9c-410acb515bc2 | 2026-01-23 | Warnings | M012 |
| Daytime cold and flu non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Meijer Distribution Inc | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 2026-01-23 | Warnings | M012 |
| good neighbor pharmacy night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7 | 2026-01-23 | Warnings | M012 |
| RAYO ACTIVE ICE | MENTHOL, CAMPHOR | Quimicas Handal de Centroamerica SA de CV | 09e4a36b-020a-c5b1-e063-6394a90a3e31 | 2026-01-22 | Warnings | M012 |
| DRX CHOICE NIGHTTIME COLD and FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc. | f466fc0e-3384-4884-832e-99bf1fdcf899 | 2026-01-21 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR GUAIFENESIN | Strategic Sourcing Services LLC | 84750bfb-9e94-40a3-b731-21799f5e4fd1 | 2026-01-20 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Amerisource Bergen | 0b58990f-2246-408e-9365-51f56bb6766c | 2026-01-20 | Warnings | M012 |
| NightTime Cold and Flu Multi Symptom | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | a8460fc9-2d08-4e5f-8dd3-5135ecda5923 | 2026-01-20 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Family Dollar Services Inc | 0a651316-623e-41eb-ab3a-641f5d807425 | 2026-01-20 | Warnings | M012 |
| Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu | WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU | Walgreens | 579c47c8-6366-4785-9680-d3986ce9641d | 2026-01-19 | Warnings | M012 |
| Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold | WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD | Walgreens | dd61c9d3-0b70-450e-9525-282710b383cc | 2026-01-19 | Warnings | M012 |
| Sinus Severe Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 48bf7422-38ef-d4b4-e063-6294a90aa3ab | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | fc670515-a820-4ea7-8786-8ae710798b31 | 2026-01-19 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | WALGREENS | 9dece7b1-00b1-2499-e053-2a95a90a0be3 | 2026-01-19 | Warnings | M012 |
| SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 2dba2bec-e0e3-4910-89c5-ebc093e05bec | 2026-01-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1550968 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Powder for Oral Solution | PSN | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
| 1550968 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SCD | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
| 1550968 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Granules for Oral Solution | SY | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
| 1550968 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 400 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution | SY | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0921-06 | 00280092106 | 6 PACKET in 1 CARTON (0280-0921-06) > 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2014-04-17 | 0000-00-00 | No | No | Current |