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 |
|---|---|---|---|---|---|---|
| Ephedrine Sulfate | EPHEDRINE SULFATE | Walgreen Company | dc0072f9-7111-1af0-e053-2a95a90aed56 | 2025-09-04 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS Pharmacy, Inc | 31aa77e0-cfdb-57a8-e063-6394a90af98c | 2025-09-04 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | CVS Pharmacy, Inc. | 4bb70a55-de44-3dc1-e054-00144ff8d46c | 2025-09-04 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | CVS PHARMACY | a645b31e-7da7-4fe6-a04f-ac794ef52494 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de637b1-3402-db86-e063-6294a90ac981 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | f4a9cfec-0725-8f4a-e053-2995a90a1b4a | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de65c99-6c2d-3650-e063-6394a90aa98c | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Medical Group Care LLC | f4a9d879-4736-4f63-e053-2995a90adeba | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de66240-441c-00ad-e063-6294a90a4a05 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | ff99c57a-e06a-69d3-e053-6394a90a6775 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de7ace0-e389-b751-e063-6394a90ab4e9 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | DISCOUNT DRUG MART | 06673358-1afc-4d75-e063-6394a90a6ab1 | 2025-09-03 | Warnings | M012 |
| ValuMeds Cough Relief, Dextromethorphan Hbr | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | b16a81db-d9bc-4cce-8ec2-dc189184931e | 2025-09-03 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 256d96f0-67bf-42d2-85ef-f49625c5910f | 2025-09-02 | Warnings | M012 |
| TOPCARE HONEY FLAVOR COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 2256623c-7642-4c39-b022-bfaecc861f1c | 2025-09-02 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ef574f18-e28d-46bb-87fd-2f3b4df6dc68 | 2025-09-02 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger Company | f4429475-47f9-451a-bfcc-24b5ef333923 | 2025-09-02 | Warnings | M012 |
| dg health night time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 2025-08-29 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Medical Group Care LLC | 3d70ba70-eb11-f148-e063-6294a90a4c7c | 2025-08-28 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Army & Air Force Exchange Service | 3d7109a5-4fe1-039b-e063-6394a90a1392 | 2025-08-28 | 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 |