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 | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Vicks childrens Cough Congestion | PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | The Procter & Gamble Manufacturing Company | e2356457-9791-3710-e053-2995a90ad140 | 2026-09-08 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 077fac1a-0ec5-40d9-8861-a281b48f650a | 2026-09-08 | Warnings | M012 |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | RARITAN PHARMACEUTICALS | eef00453-9f4f-4a05-bb4e-49b94705b52c | 2026-09-08 | Warnings | M012 |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | RARITAN PHARMACEUTICALS INC | 9819155b-2713-42be-867e-16605e7643d0 | 2026-09-08 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | WALMART INC. | f9d1dfd1-527f-491d-9188-14886ac70ced | 2026-09-08 | Warnings | M012 |
| severe cold and cough daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | RARITAN PHARMACEUTICALS INC | 3ce8508e-7d9d-4413-858a-8f952e760c01 | 2026-09-08 | Warnings | M012 |
| Multi Symptom Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS INC | d9606c9a-31b1-4121-9870-809a05f5b68a | 2026-09-08 | Warnings | M012 |
| Mucus Relief DM Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RARITAN PHARMACEUTICALS INC | 4898b1c2-55ef-4589-982b-2279c01707e5 | 2026-09-08 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 2a7afe03-3c34-4e30-827e-b3bb2568cb97 | 2026-09-08 | Warnings | M012 |
| Drx Choice childrens allergy chews | DIPHENHYDRAMINE HCL | RARITAN PHARMACEUTICALS INC | dd2be906-bd0a-437c-9693-54b9391a5da3 | 2026-09-05 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 49235f4f-e661-4a83-88ef-b9a956848777 | 2026-09-04 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 71845bf9-8981-4ca0-a62c-dbef102b1b02 | 2026-09-04 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 774d2bde-9f57-4ced-800a-cada39c685ed | 2026-09-04 | Warnings | M012 |
| Nostrilla | OXYMETAZOLINE HYDROCHLORIDE | Insight Pharmaceuticals LLC | 86217847-8e2b-48cc-b289-4987fd3aa7c3 | 2026-09-04 | Warnings | M012 |
| tussin cough chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 86fc3723-5fc5-4de5-bd04-7774c2abe539 | 2026-09-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | ed576bf1-3949-423e-af2e-e4b1a3839b21 | 2026-09-04 | Warnings | M012 |
| tussin nighttime cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 80d51af8-3a7b-4d22-8d4f-df5f91913047 | 2026-09-04 | Warnings | M012 |
| NO MORE NOSEBLEED | OXYMETAZOLINE HYDROCHLORIDE | DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. | 69d3f1fe-b476-4f84-8c5e-94957b74b46c | 2026-09-04 | Warnings | M012 |
| Ultra Fine Mist Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | DOLGENCORP, INC. | 5f134840-2465-4585-a85d-08d746f76f7a | 2026-09-03 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE | Family Dollar (FAMILY WELLNESS) | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 2026-09-03 | 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 |