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 |
|---|---|---|---|---|---|---|
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Family Dollar Services Inc | 8aee8108-a4e0-4956-8e37-6b3b1c5dc683 | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion Relief | GUAIFENESIN | TOPCO ASSOCIATES LLC | b8339617-17ce-4ad7-af38-399ecc74d864 | 2024-12-18 | Warnings | M012 |
| Kroger Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | THE KROGER CO | 976bfdcf-2110-486c-aa6e-cd2067334cdc | 2024-12-18 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | AmerisourceBergen Drug Corp | 79cefd46-bd19-4a1d-9cb1-e85ff0f12494 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Cardinal Health | 8397e1b9-e83e-4c6a-b858-1663c2365840 | 2024-12-18 | Warnings | M012 |
| GNP Mucus Relief PE | GUAIFENESIN/PHENYLEPHRINE | AmerisourceBergen Drug Corp | 63932e68-b09d-4500-bc1d-cfb2c267df1c | 2024-12-18 | Warnings | M012 |
| Meijer Chest Congestion Relief | GUAIFENESIN | Meijer Distribution Inc. | ae02e0bd-d9e7-495f-b01f-b135b96934a0 | 2024-12-18 | Warnings | M012 |
| Topcare Chest Congestion and Sinus Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | TOPCO ASSOCIATES LLC | b6c0362f-86ca-4f08-ba53-800c6df2c025 | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 10cad9a7-1223-470c-9027-807891217d40 | 2024-12-18 | Warnings | M012 |
| Kroger Mucus Relief | GUAIFENESIN | THE KROGER CO | 2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | 41f88b43-3e0a-4650-b167-a72afe6177e8 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Rugby Laboratories | 5da36516-9f94-49cb-9421-0c310abcd116 | 2024-12-18 | Warnings | M012 |
| Kroger Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | THE KROGER CO | 430c6604-93a7-4df6-a657-ba438aa61425 | 2024-12-18 | Warnings | M012 |
| Discount Drugmart Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart, Inc | 1ac281e1-22ea-42f8-98fe-ab3d5ff9a208 | 2024-12-18 | Warnings | M012 |
| TopCare Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | 4c50233e-1dcb-427d-ba63-1538cf370061 | 2024-12-18 | 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 |