Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night
- Product NDC
- 0280-1138
- 11-digit product format
- 002801138
- Labeler code
- 0280
- Product ID
- 0280-1138_2be95d4a-3001-97e4-e063-6294a90a5f3f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-07-15
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 0280-1138 | 0280-1138-20 | 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0280-1138-20 | D | Discontinued by firm | 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 Multi-Symptom Cold and Flu Day and Night
- Brand name suffix
- Liquid Gels
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 34b2e77f-5d04-15a7-e054-00144ff8d46c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1138-20 | Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and NightLiquid Gels | 1 in 1 CARTON | KIT | 1 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-1138 | ALKA-SELTZER PLUS MULTI-SYMPTOM COLD AND FLU DAY AND NIGHT LIQUID GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [BAYER HEALTHCARE LLC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250119_34b2e77f-5d04-15a7-e054-00144ff8d46c.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 |
|---|---|---|---|---|---|---|
| TARGET CHILDRENS DT AND NT COLD and COUGH | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | TARGET CORPORATION | 05ac2a40-5eee-4013-b55b-6e370a28b21c | 2025-11-05 | Warnings | M012 |
| TARGET CHILDRENs COLD and COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | eb912834-1b14-484d-90f7-a8deb52c0d4e | 2025-11-05 | Warnings | M012 |
| UP and UP Daytime Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | a2d99bc8-7295-4922-acff-0cb02c91273c | 2025-11-05 | Warnings | M012 |
| Good Neighbor Pharmacy Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | AMERISOURCE BERGEN | c1843f1a-ae5b-0fdf-e053-2995a90aae38 | 2025-11-05 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2025-11-05 | Warnings | M012 |
| Day Time Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | Safeway, Inc. | 76d62892-615d-4744-95aa-3be1207a0e57 | 2025-11-05 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway, Inc. | 6fefff08-13b0-47eb-aa32-8d7e4deeae7b | 2025-11-05 | Warnings | M012 |
| Menthol Drops Freegells Extra Strong Eucalyptus 30ct | MENTHOL | R.L. ALBERT & SON, INC | 165a8efa-2b03-4329-99fa-3233f0af7d08 | 2025-11-04 | Warnings | M012 |
| Menthol Drops Freegells Extra Strong Honey Lemon 30ct | MENTHOL | R.L. ALBERT & SON, INC | f9ea46fc-0b04-444e-95fc-09aff7e7978a | 2025-11-04 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40413cdb-68ac-70e1-e063-6394a90a9217 | 2025-11-04 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | WinCo Foods, LLC | 73fec783-1594-447b-b059-49ea9dbb5bee | 2025-11-04 | Warnings | M012 |
| Texaclear Fast Acting Allergy Relief | CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 17a2f643-fa98-21ee-e054-00144ff88e88 | 2025-11-03 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e618bc7-0f51-e586-e063-6294a90afe37 | 2025-11-03 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e61b5b3-ad15-01bf-e063-6394a90a6ec3 | 2025-11-03 | Warnings | M012 |
| Cold plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 409540c0-1bab-9969-e063-6394a90a47c1 | 2025-11-03 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e60b340-bd60-9318-e063-6294a90ad079 | 2025-11-03 | Warnings | M012 |
| Sinus Pressure and Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e60e32f-3e5f-b775-e063-6294a90a097d | 2025-11-03 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e614265-b35a-5d01-e063-6294a90aad85 | 2025-11-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e60b0ed-889d-0f17-e063-6394a90a4694 | 2025-11-03 | Warnings | M012 |
| VANACOF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | 2ed699f2-d004-4fa9-8042-6c85a9ff69b6 | 2025-11-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634363 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 2634363 | 1 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 2634363 | 1 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 7 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0280-1138-20 | 00280113820 | 1 in 1 CARTON | Historical |