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 | 2026-10-20 |
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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2771d699-3f70-4318-e063-6394a90a89cc | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b | 2025-12-09 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 9a32bc6d-0499-48fa-a6ad-702c8a28bf5f | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 5015a380-a229-4eff-8e31-528065c6ed64 | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | caf59320-5b48-4533-bda9-7b03a2fde0b5 | 2025-12-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 30d41dc3-e2ef-4cad-b63c-d634bc749aa1 | 2025-12-09 | Warnings | M012 |
| Walgreens Childrens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a7226-84b9-26d7-e063-6394a90a99b9 | 2025-12-09 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Meijer Distribution Inc | 8ed5b802-a26e-45b4-a696-bc64dbac4733 | 2025-12-09 | Warnings | M012 |
| dg health cold plus flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ff4a2f0a-d638-4ed2-8e05-2a52afbc4909 | 2025-12-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 24894484-b834-4b2f-b365-c95b5e30d8bf | 2025-12-09 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Family Dollar (FAMILY WELLNESS) | 2c431220-c61b-4ad5-9ad2-58ccaee2d1c3 | 2025-12-09 | Warnings | M012 |
| Sinus PE Congestion Daytime Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9da77306-5098-4c79-845c-97ead849c84a | 2025-12-08 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fdd0dadc-5313-4f6e-aef5-ca853efe5c4d | 2025-12-08 | Warnings | M012 |
| Mucolyte | GUAIFENESIN | Rising Pharma Holdings, Inc. | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 2025-12-08 | Warnings | M012 |
| Mucolyte DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rising Pharma Holdings, Inc. | c913d27d-bc00-4ace-9a5f-c55522e1cd1d | 2025-12-08 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | American Sales | 47f504d5-3ec5-5227-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | American Sales | 4893ac0a-7769-5657-e054-00144ff8d46c | 2025-12-07 | Warnings | M012 |
| Cherry cough drop | MENTHOL | American Sales | 45e891ea-2f2a-31b7-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Cherry Sore Throat Lozenge | BENZOCAINE | American Sales | 49248a40-1ca3-6dd1-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | American Sales | 4896cbd1-57dd-1fc6-e054-00144ff8d46c | 2025-12-07 | 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 |