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 | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f40bfdfc-1cb4-4604-9790-fb8d1d5173c6 | 2025-01-31 | Warnings | M012 |
| NIGHTIME COLD AND FLU | NIGHTIME COLD AND FLU | TARGET CORP | 9dee9b92-eac9-b07d-e053-2995a90a0602 | 2025-01-31 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Bryant Ranch Prepack | 7b23faa9-40c8-4cea-b9fb-487cce2664af | 2025-01-31 | Warnings | M012 |
| BENADRYL Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 224ba2a3-1a93-29c8-e063-6394a90a9bef | 2025-01-30 | Warnings | M012 |
| Extra Strength Nite-Time Pain Relief | 430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET | WALGREENS | c25cff5a-93f5-62aa-e053-2a95a90aa7b4 | 2025-01-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WALGREENS | dbf5c814-4e69-13ac-e053-2a95a90a49a3 | 2025-01-30 | Warnings | M012 |
| Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | WALGREENS | f3770976-de73-52b8-e053-2995a90aad4f | 2025-01-30 | Warnings | M012 |
| Dextromethorphan HBr and Guaifenesin Oral Solution | DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION | KESIN PHARMA CORPORATION | 284eae44-81bc-400c-e063-6394a90af446 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26c82bc3-5753-4d56-96a4-a3f9c8c267d0 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8095b211-8ae7-44e5-b89a-b7f730e28d51 | 2025-01-30 | Warnings | M012 |
| Vapor Shower | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2cf2f35b-5d59-e3ff-e063-6294a90a9b45 | 2025-01-30 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy, Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5 | 2025-01-30 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | RB Health (US) LLC | 2ce20ab5-5f2d-1c97-e063-6394a90ad67b | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 97b137c9-0bec-409a-91f7-e298c296578b | 2025-01-29 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS | 1dc17665-62ce-f7f5-e063-6294a90af851 | 2025-01-29 | 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 |