Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night
- Product NDC
- 0280-0506
- 11-digit product format
- 002800506
- Labeler code
- 0280
- Product ID
- 0280-0506_45266d30-bb3b-21f8-e063-6294a90a29cf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride, Guaifenesin
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-05-30
- 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 Severe Cough Mucus and Congestion Day and Night
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5278a128-41ec-4494-e054-00144ff8d46c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0506-20 | Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night | 1 in 1 CARTON | KIT | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0506 | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION DAY AND NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN) KIT [BAYER HEALTHCARE LLC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231205_5278a128-41ec-4494-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 |
|---|---|---|---|---|---|---|
| Cold and Allergy | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Allegiant Health | 7af63769-fa56-4f1f-a2ad-5b4c108c8e4f | 2019-12-12 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN | Allegiant Health | 221d64a2-b8c7-435a-aae4-fb58fd38108f | 2019-03-26 | Warnings | M012 |
| Sleep Tabs For Nighttime use | DIPHENHYDRAMINE HCL TABLETS | Allegiant Health | 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d | 2018-12-26 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Allegiant Health | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 2018-12-26 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | dbbc535f-515a-4d9b-b799-34e60f5230bb | 2018-12-21 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Allegiant Health | c2823bad-540f-4662-8dcc-58e9f0d94efb | 2018-11-07 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength Non-Drowsy | PHENYLEPHRINE 10 MG | Allegiant Health | 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 | 2018-11-07 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a58bfb14-28f9-4425-a5a5-aaff4847c979 | 2018-03-14 | Warnings | M012 |
| Chlorpheniramine maleate 4mg | CHLORPHENIRAMINE MALEATE 4MG | Athlete's Needs, Inc. | 4d974959-25fc-4707-9b72-9afbf47b76f1 | 2017-11-14 | Warnings | M012 |
| Cold Medicine | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Selder, S.A. de C.V. | d2762d9c-e7e7-42b2-a26a-14b2aa0307cb | 2017-01-25 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Marc Glassman, Inc. | 2051247f-ce64-4cf5-b449-9ca14c43ab86 | 2016-12-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1927849 | {1 (acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1927849 | 1 daytime (acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 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 | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1432488 | acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1432488 | acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1927849 | 1 daytime (acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) Pack | SY | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1432488 | APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 5278a128-41ec-4494-e054-00144ff8d46c | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0506-20 | 00280050620 | 1 KIT in 1 CARTON (0280-0506-20) * 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 | 2017-05-30 | 0000-00-00 | No | No | Current |