Alka-Seltzer Plus Cold Night
- Product NDC
- 0280-1545
- 11-digit product format
- 002801545
- Labeler code
- 0280
- Product ID
- 0280-1545_45267736-ecae-d911-e063-6294a90a98bc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate
- Dosage form
- TABLET, EFFERVESCENT
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-09-14
- Substance
- ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE
- Active strength
- 500; 10; 6.25; 7.8 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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 Cold Night
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| PHENYLEPHRINE BITARTRATE | 7.8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 27O3Q5ML57 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1536503 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7588ea67-68a9-4dc0-e053-2991aa0aa471 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1545-20 | Alka-Seltzer Plus Cold Night | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 6 | |
| 0280-1545-20 | Alka-Seltzer Plus Cold Night | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1545-20 | EA - Each | 0280-1545 | f9b5da63-1386-4d16-a784-ded8eefd8c79 | 1 | 2022-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-1545 | ALKA-SELTZER PLUS COLD NIGHT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231205_7588ea67-68a9-4dc0-e053-2991aa0aa471.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 |
|---|---|---|---|---|---|---|
| COLD MAX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a1aba467-c91f-4812-b0b9-ff5fdfa298e3 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dd12f1-dd63-27ae-e053-2995a90aaaeb | 2024-10-17 | Warnings | M012 |
| COLD and FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e44ac549-3e9b-4271-a2b2-ecb124f79832 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | f171a389-8b22-429c-86bc-272156fdc1b7 | 2024-10-17 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 6c5b5427-e47a-4eff-928a-c891452facf9 | 2024-10-17 | Warnings | M012 |
| COLD AND FLU SEVERE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20baef9-6e68-6679-e053-2a95a90a2b63 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20b71fb-8787-c871-e053-2a95a90a8eb4 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20bc492-fed3-bf05-e053-2a95a90ad393 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | a4d6ecb9-ea67-41ed-917b-9bb4d1e50551 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 08fda81a-bedd-4ff3-9c32-2066d2cea3f9 | 2024-10-17 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | American Health Packaging | 2fd702ea-3069-472c-b99e-c527f1375705 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Selder, S.A. de C.V. | c2b49d10-b60f-3072-e053-2a95a90af004 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 1db914d3-8bba-405e-9bf9-9b1a5806284c | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | e2c35fae-9dd6-51f2-e053-2995a90a1e9e | 2024-10-17 | Warnings | M012 |
| Cough and Cold XL3 Xtra | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | MIDWAY IMPORTING INC. | 58252f15-485c-3061-e053-2a91aa0a2320 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Midway Importing, Inc. | e41b9beb-e274-5c02-e053-2995a90ad0f8 | 2024-10-17 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 38e70a28-eff2-4a48-b829-8cd68e80beef | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Midway Importing Inc. | c2c8bd26-bbf1-c2e6-e053-2995a90a86a7 | 2024-10-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1536503 | aspirin 500 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 6 |
| 1536503 | aspirin 500 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 6 |
| 1536503 | ASA 500 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-1545-20 | 00280154520 | 10 POUCH in 1 CARTON (0280-1545-20) / 2 TABLET, EFFERVESCENT in 1 POUCH | 10 pouch | 2018-09-14 | 0000-00-00 | No | No | Current |