Alka-Seltzer Plus Severe Cough Mucus and Congestion
- Product NDC
- 0280-0505
- 11-digit product format
- 002800505
- Labeler code
- 0280
- Product ID
- 0280-0505_45266194-8eb1-21f4-e063-6294a90af1dc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alka-Seltzer Plus Severe Cough Mucus and Congestion
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-01-07
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 5; 250; 200; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Severe Cough Mucus and Congestion
- Brand name suffix
- Liquid Gels
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| ACETAMINOPHEN | 250 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1432488 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0c120569-622d-3a23-e054-00144ff88e88 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0505-20 | Alka-Seltzer Plus Severe Cough Mucus and CongestionLiquid Gels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 8 | |
| 0280-0505-20 | Alka-Seltzer Plus Severe Cough Mucus and CongestionLiquid Gels | 20 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 20 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0505-20 | EA - Each | 0280-0505 | 8ea7a7fc-a2ac-494d-b781-d53a2a33533b | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0505 | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION LIQUID GELS (ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231205_0c120569-622d-3a23-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 |
|---|---|---|---|---|---|---|
| Halls Sugar Free Black Cherry | MENTHOL | Mondelez Global LLC | bd2a311a-bf0c-4365-af9b-76675c243b22 | 2025-03-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | TARGET CORPORATION | fbca9627-5e12-048a-e053-6294a90a6e0f | 2025-03-15 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | DOLGENCORP, INC. | 0655688e-7c42-507f-e063-6294a90ae498 | 2025-03-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 2025-03-14 | Warnings | M012 |
| Ultra Concentrated Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300b2357-933b-fe9a-e063-6294a90aa4b9 | 2025-03-11 | Warnings | M012 |
| Ultra Concentrated Nighttime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | PuraCap Pharmaceutical LLC | 300bf27f-744f-7366-e063-6394a90acbcb | 2025-03-11 | Warnings | M012 |
| Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 2025-03-11 | Warnings | M012 |
| Rompe Pecho Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EFFICIENT LABORATORIES INC | 2ec319a8-92bf-4552-86dd-37cbce18980f | 2025-03-11 | Warnings | M012 |
| HISTEX-DM New Formulation | DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI | Allegis Pharmaceuticals, LLC | 30010401-e5b4-2bd9-e063-6394a90a0b0b | 2025-03-10 | Warnings | M012 |
| daytime severe cold multi-symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd | 2025-03-08 | Warnings | M012 |
| Cold and Head Congestion Relief Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | a39778ba-1f63-4495-8e9b-44b0bdd7f71a | 2025-03-08 | Warnings | M012 |
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Day | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 2e9540e4-bd1d-9370-e063-6294a90affcb | 2025-03-07 | Warnings | M012 |
| Herbal Cough Drops Original Herb | COUGH DROPS | Topco Associates LLC | 2fb22181-aee3-d0bf-e063-6294a90a7865 | 2025-03-06 | Warnings | M012 |
| REVASOL DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Rnv LLC | 2f9ddcc3-b913-f8b0-e063-6294a90a93ab | 2025-03-05 | Warnings | M012 |
| Herbal Throat Drops Lemon Mint Herb | THROAT DROPS | Topco Associates LLC | 2fa086b4-3b0e-0df8-e063-6294a90a6769 | 2025-03-05 | Warnings | M012 |
| Redicare Nasal and Sinus Decongestant | REDICARE NASAL AND SINUS DECONGESTANT | Redicare LLC | 2f24be68-f30e-d916-e063-6294a90a7e31 | 2025-03-04 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL SOLUTION | Kesin Pharma Corporation | 2f871005-de4d-8b2a-e063-6394a90aa43a | 2025-03-04 | Warnings | M012 |
| CVS Daytime Cough Relief Chews - Citrus Punch | DEXTROMETHORPHAN HBR | CVS | 2f885f1b-7ff5-251b-e063-6394a90a656f | 2025-03-04 | Warnings | M012 |
| CVS Dex-Dox Kids Nighttime Cough Suppressant | DEXTROMETHORPHAN HBR | CVS | 2f8b6f5e-399c-b033-e063-6294a90ac3d1 | 2025-03-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ff8b096c-8f01-4a8c-a98f-e4aa4d688e95 | 2025-03-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1432488 | acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 0c120569-622d-3a23-e054-00144ff88e88 | 8 |
| 1432488 | acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 0c120569-622d-3a23-e054-00144ff88e88 | 8 |
| 1432488 | APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 0c120569-622d-3a23-e054-00144ff88e88 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0505-20 | 00280050520 | 2 BLISTER PACK in 1 CARTON (0280-0505-20) / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2015-01-07 | 0000-00-00 | No | No | Current |