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 |
|---|---|---|---|---|---|---|
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | b9772292-9eb6-47cf-abb8-007c25478090 | 2024-03-17 | Warnings | M012 |
| Childrens Robitussin Cough Long-Acting | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 75bc7827-4439-e6a8-a65c-7154d5592e58 | 2024-03-17 | Warnings | M012 |
| Childrens Robitussin Nighttime Cough Long-Acting DM | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c | 2024-03-17 | Warnings | M012 |
| ANTIGRIP Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Pharmadel LLC | 12f20aba-f991-bd82-e063-6294a90a4aac | 2024-03-16 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | WALGREENS | d3053f80-aece-eb50-e053-2a95a90a5945 | 2024-03-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL | WALGREENS | d315bc95-1b46-75df-e053-2a95a90a6c66 | 2024-03-15 | Warnings | M012 |
| MAR-COF CG Expectorant | CODEINE PHOSPHATE AND GUAIFENESIN | Marnel Pharmaceuticals, LLC | 60a41229-b125-43d8-b2b4-0bf40feed764 | 2024-03-15 | Warnings | M012 |
| Night Time Cough | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY, INC | 97aa0b90-1230-4143-b5d3-18b96a6b7b4f | 2024-03-15 | Warnings | M012 |
| Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | 036162c9-f5a6-418e-bd5e-ebd72097d27d | 2024-03-15 | Warnings | M012 |
| Bronkaid Max | EPHEDRINE SULFATE | Foundation Consumer Healthcare LLC | 9a0b792a-caee-41f6-9400-922a5ebd592f | 2024-03-14 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | A-S Medication Solutions | 5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2 | 2024-03-12 | Warnings | M012 |
| Coricidin HBP Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE | A-S Medication Solutions | ffcae882-0b19-4219-bbee-a175c63d79c8 | 2024-03-11 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 18dcede2-5a38-40fa-93fe-48acdd6a7cf1 | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | d4ce06aa-776f-45e4-a1a6-9cf13797048f | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2024-03-08 | Warnings | M012 |
| Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 68d3e88a-d1be-410b-92a1-863903b3aa61 | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 0d3b1bea-e2ca-4e07-8ae5-60627d230c96 | 2024-03-08 | Warnings | M012 |
| Theraflu PowerPods Daytime Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | e655c33c-c319-41d9-ae55-cf747242cd10 | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | adf33520-4689-4de2-b9d8-c201518e9d26 | 2024-03-08 | Warnings | M012 |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7 | 2024-03-07 | 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 |