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 |
|---|---|---|---|---|---|---|
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | DISCOUNT DRUG MART | 06673358-1afc-4d75-e063-6394a90a6ab1 | 2025-09-03 | Warnings | M012 |
| ValuMeds Cough Relief, Dextromethorphan Hbr | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | b16a81db-d9bc-4cce-8ec2-dc189184931e | 2025-09-03 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 256d96f0-67bf-42d2-85ef-f49625c5910f | 2025-09-02 | Warnings | M012 |
| TOPCARE HONEY FLAVOR COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 2256623c-7642-4c39-b022-bfaecc861f1c | 2025-09-02 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ef574f18-e28d-46bb-87fd-2f3b4df6dc68 | 2025-09-02 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger Company | f4429475-47f9-451a-bfcc-24b5ef333923 | 2025-09-02 | Warnings | M012 |
| dg health night time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 2025-08-29 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Medical Group Care LLC | 3d70ba70-eb11-f148-e063-6294a90a4c7c | 2025-08-28 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Army & Air Force Exchange Service | 3d7109a5-4fe1-039b-e063-6394a90a1392 | 2025-08-28 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Medical Group Care LLC | 3d710deb-e42d-13eb-e063-6394a90a56e1 | 2025-08-28 | Warnings | M012 |
| Sinus Relief Pressure and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 98de5cff-3ff5-49b0-bef9-5b9ebb86491e | 2025-08-27 | Warnings | M012 |
| Nighttime SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 0a178114-0748-4a92-9b60-a7a0a8b72287 | 2025-08-26 | Warnings | M012 |
| Adult Bisolvine Adult | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 8cde5e39-a338-45af-b847-3823627f29c5 | 2025-08-25 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 997eb228-09cb-47ad-acbb-363b05c67635 | 2025-08-25 | Warnings | M012 |
| QUALITY CHOICE Childrens Allergy Relief DYE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 644f39d8-7cd6-43dd-9265-546d01d32e8c | 2025-08-22 | Warnings | M012 |
| SanaTos Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | df260190-89e7-b338-e053-2995a90a32cb | 2025-08-22 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | VerityRx | 9ca6c0f8-71d1-4953-8e98-3311c4664011 | 2025-08-22 | Warnings | M012 |
| SU PHEDRINE PE Non-Drowsy, Maximum Strength | PHENYLEPHRINE HCL | Salado Sales, Inc. | 9056fa58-d6aa-4df5-97e0-9be3f2332f86 | 2025-08-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | MY IMPORTS USA LLC | 3cde0c23-5c5c-9715-e063-6294a90a9462 | 2025-08-21 | Warnings | M012 |
| Severe Cold Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 2025-08-20 | 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 |