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 | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a401eb92-60b6-427d-a677-29371a3150be | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7c18e95-8d7b-4550-9a20-fc704a114adb | 2026-05-12 | Warnings | M012 |
| Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 66543190-1d3d-4259-ae73-d366ecbf9e52 | 2026-05-12 | Warnings | M012 |
| basic care daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 612719a9-fa2e-4c40-8f35-a399aeaafecc | 2026-05-12 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 3cac44ad-1835-487e-b6d0-1483d724bb5e | 2026-05-12 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | Cardinal Health 107, LLC | 9cfb1abb-98c4-4e90-8dd7-fcffc112f988 | 2026-05-12 | Warnings | M012 |
| Nasal Decongestant PE and Pain Relief Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab51b36-1c2e-4c97-932c-dacfaf55935a | 2026-05-11 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa | 2026-05-11 | Warnings | M012 |
| NebuClear MD | SALINE | Blue Echo Care LLC | 3f85fe62-230f-b0f1-e063-6394a90a5cb8 | 2026-05-11 | Warnings | M012 |
| Device - NebuClear MD Hand-held Rubber Bulb Nebulizer | DEVICE - HAND-HELD RUBBER BULB NEBULIZER | Blue Echo Care LLC | 43e0a646-be57-1024-e063-6394a90a43e4 | 2026-05-11 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 1efd1778-7ab1-4797-98c5-4637940ee3ec | 2026-05-11 | Warnings | M012 |
| DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR | AptaPharma Inc. | 0380035e-44d5-44ea-9d1c-d57a1de65188 | 2026-05-10 | Warnings | M012 |
| Night Time Cold and Flu relief liquid filled softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE | AptaPharma Inc. | d61e2186-8b59-45f9-96ec-83430a0fe0cb | 2026-05-10 | Warnings | M012 |
| Maximum Strength Tussin DM Liquid filled Softgels | DEXTROMETHORPHAN HBR, GUAIFENESIN | AptaPharma Inc. | 39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1 | 2026-05-10 | Warnings | M012 |
| Day-Time Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c | 2026-05-10 | Warnings | M012 |
| Daytime Cold and Flu Relief Liquid Filled Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | c078efb5-d30e-4dd1-a600-6e827390df76 | 2026-05-10 | Warnings | M012 |
| DM Max CONGESTION and COUGH | DEXTROMETHORPHAN HBR, GUAIFENESIN | DeMoulas Market Basket | b12e26b2-79e4-45a5-9a90-4630f92457d0 | 2026-05-09 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Walgreen Company | fac55d76-457f-4258-9cc8-6edae539cada | 2026-05-08 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | HyVee Inc | 5a0ef8ae-f6d5-4388-b4da-6b7f025160b2 | 2026-05-08 | 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 |