Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu
- Product NDC
- 0280-1580
- 11-digit product format
- 002801580
- Labeler code
- 0280
- Product ID
- 0280-1580_45267a4c-d228-b1b5-e063-6394a90a81bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-05-22
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 Maximum Strength Day and Night Cold and Flu
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 51c44970-06e5-082e-e054-00144ff88e88 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1580-20 | Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | 1 in 1 CARTON | KIT | 1 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-1580 | ALKA-SELTZER PLUS MAXIMUM STRENGTH DAY AND NIGHT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [BAYER HEALTHCARE LLC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240821_51c44970-06e5-082e-e054-00144ff88e88.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 |
|---|---|---|---|---|---|---|
| TheraCare Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | d6e789c7-a55a-dc9a-e053-2a95a90a2bdb | 2024-10-29 | Warnings | M012 |
| Careone daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | American Sales Company | 31187c98-6706-4962-91f6-022a390cda39 | 2024-10-28 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 0100f86e-257f-4197-9849-3c4429cdf0f2 | 2024-10-28 | Warnings | M012 |
| Premier Value Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 46bf124a-a44f-4066-b936-852d46da8f40 | 2024-10-28 | Warnings | M012 |
| Signature Care Non drowsy Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | 25a26577-a9f8-49cb-9d75-d8c471e4aaf6 | 2024-10-28 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e | 2024-10-28 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | d38537c6-9553-4e93-a83e-11ed48c955ab | 2024-10-28 | Warnings | M012 |
| Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 2b3a1997-f382-4843-a44b-d80d1ad21a90 | 2024-10-28 | Warnings | M012 |
| Premier Value Tussin Cough Long Acting | DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | 0e393287-5bb8-458b-98c4-55fa16674d06 | 2024-10-28 | Warnings | M012 |
| daytime cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1740ccfc-6e68-46f4-a1ba-48fe092f0aa0 | 2024-10-28 | Warnings | M012 |
| night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | d3bd0632-328c-4ad7-bb44-8383e1e51b8c | 2024-10-28 | Warnings | M012 |
| Premier Value | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 1ae3c6ac-1646-4c67-a9d5-9c383924b81a | 2024-10-28 | Warnings | M012 |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 2024-10-25 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | b6d9f421-b236-4660-be7f-85a878f2fc61 | 2024-10-25 | Warnings | M012 |
| COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | f9c3c12b-4efa-4ec4-a156-c403aff81753 | 2024-10-24 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | 1deb60f3-e9be-4756-b0c1-527ef00dc741 | 2024-10-24 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | 51dd467b-aae8-41fa-e054-00144ff8d46c | 2024-10-24 | Warnings | M012 |
| Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 68a5930b-37db-439d-8fb9-7d7de07d8465 | 2024-10-24 | Warnings | M012 |
| sinus pressure pain and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | bb0225d5-6c32-2c64-e053-2995a90a829b | 2024-10-24 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148 | 2024-10-24 | 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 | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 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 | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 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 | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 51c44970-06e5-082e-e054-00144ff88e88 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-1580-20 | 00280158020 | 1 KIT in 1 CARTON (0280-1580-20) * 2 BLISTER PACK in 1 CARTON / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2017-05-22 | 0000-00-00 | No | No | Current |