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 |
|---|---|---|---|---|---|---|
| UP AND UP NO DRIP NASAL | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 760d6d0f-00fc-40bc-858d-83a0827d139f | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 51e48201-bb62-4e89-85eb-e4a416f93522 | 2025-01-29 | Warnings | M012 |
| Severe Congestion and Cough Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 8c878e47-94f4-484f-bdd8-6d87ac2440d8 | 2025-01-28 | Warnings | M012 |
| Cough and Cold Therapy | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088be461-7afc-586a-e063-6294a90a700b | 2025-01-27 | Warnings | M012 |
| Cough and Cold Therapy For Kids | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088df369-114c-db4f-e063-6394a90acfac | 2025-01-27 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a | 2025-01-26 | Warnings | M012 |
| Walgreens Menthol Cough Drops | MENTHOL | Walgreens | 2c62f690-8dfb-d28e-e063-6394a90a45a2 | 2025-01-23 | Warnings | M012 |
| Walgreens Cherry Cough Drops | MENTHOL | Walgreens | 2c65d836-e724-50d6-e063-6394a90a0827 | 2025-01-23 | Warnings | M012 |
| Walgreens Honey Lemon Cough Drops | MENTHOL | Walgreens | 2c67424c-2fb0-cc15-e063-6394a90a02ca | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Analgesic Gel | MENTHOL | American Consumer Products Corp | 6f0725f2-833f-f3a0-e053-2a91aa0a3911 | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 6ef328ff-f5c3-515d-e053-2a91aa0a32d3 | 2025-01-23 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Best Choice | 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d | 2025-01-22 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 26a02737-2cfd-769f-e063-6394a90af352 | 2025-01-22 | Warnings | M012 |
| Pharbechlor | CHLORPHENIRAMINE MALEATE 4MG | Ulai Health LLC | 6a1a5cef-e946-4ba8-9402-557c6adf45f9 | 2025-01-20 | Warnings | M012 |
| Pharbinex | GUAIFENESIN 400MG | Ulai Health LLC | 4eafa81a-aeee-4c97-85d6-594902b10919 | 2025-01-20 | M012 | |
| Pharbinex-PE | GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG | Ulai Health LLC | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 2025-01-20 | M012 | |
| Pharbinex-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Ulai Health LLC | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 2025-01-20 | M012 | |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 0280-1138 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | 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 |