Alka-Seltzer Plus Night Severe Cold and Flu
- Product NDC
- 0280-0922
- 11-digit product format
- 002800922
- Labeler code
- 0280
- Product ID
- 0280-0922_47e3298a-8540-598c-e063-6294a90ada28
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, 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; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 | 0280-0922 | 0280-0922-06 | D | Discontinued by firm | 2026-10-28 |
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 Night Severe Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| DOXYLAMINE SUCCINATE | 12.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1534835 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0922-06 | Alka-Seltzer Plus Night Severe Cold and Flu | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 10 | |
| 0280-0922-06 | Alka-Seltzer Plus Night Severe Cold and Flu | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0922-06 | EA - Each | 0280-0922 | a204e8b1-5393-48ba-82ac-8df2d8b4fc41 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0922 | ALKA-SELTZER PLUS NIGHT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240111_f4c60ca1-ba59-4a92-84a5-6ba65faa56ab.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 |
|---|---|---|---|---|---|---|
| Theraflu Severe Cold relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 0d3b1bea-e2ca-4e07-8ae5-60627d230c96 | 2024-03-08 | Warnings | M012 |
| Theraflu PowerPods Daytime Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | e655c33c-c319-41d9-ae55-cf747242cd10 | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | adf33520-4689-4de2-b9d8-c201518e9d26 | 2024-03-08 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7 | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 62f7fcb9-e31a-4634-b1c2-44a9567e3a61 | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Severe Cold and Flu Caplets | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 8e22f6bc-33ce-4bb0-99be-7947aa21f60e | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Severe Cold and Flu Syrup | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 | 2024-03-07 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 4c6025ff-4982-4408-b077-75dd5f5b65b2 | 2024-03-07 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | 423fd5e6-5d90-4539-81e0-0ae23881ee3a | 2024-03-07 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 917df706-1982-4240-9f56-42d426b76cc5 | 2024-03-06 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 21a29998-29d6-4a36-a370-291d23bfb197 | 2024-03-05 | Warnings | M012 |
| Multi-Symptom Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 3c7ef3cf-f7f9-42bc-bf20-e36954b9671f | 2024-03-05 | Warnings | M012 |
| QUALITY CHOICE NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | da06e994-6848-4c1e-9432-31de5e626ea4 | 2024-03-02 | Warnings | M012 |
| QUALITY CHOICE DayTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 417c4fa9-6458-40d0-b22a-2415194e250f | 2024-03-02 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Aurohealth LLC | 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2 | 2024-03-01 | Warnings | M012 |
| APRODINE | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | A-S Medication Solutions | bbc268b8-fa66-4dc5-b935-f77ae39d28c8 | 2024-02-29 | Warnings | M012 |
| XtraCare Vaporizing Chest Rub | CAMPHOR, MENTHOL | Rejoice International | c3e220d6-fff4-452f-99a9-bd701fc608a0 | 2024-02-28 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 2024-02-27 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 1c93c45d-1141-4599-83ba-6d3b38f9ffc4 | 2024-02-23 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1534835 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG Powder for Oral Solution | PSN | f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | 10 |
| 1534835 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SCD | f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | 10 |
| 1534835 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SY | f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | 10 |
| 1534835 | APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / doxylamine succinate 12.5 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution | SY | f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0922-06 | 00280092206 | 6 PACKET in 1 CARTON (0280-0922-06) > 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2014-04-17 | 0000-00-00 | No | No | Current |