ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night
- Product NDC
- 0280-8272
- 11-digit product format
- 002808272
- Labeler code
- 0280
- Product ID
- 0280-8272_5349dbde-730d-610f-e063-6394a90a952a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
- 2027-12-31
- 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 COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| DOXYLAMINE SUCCINATE | 12.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1534835 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5349dbde-730c-610f-e063-6394a90a952a | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7ee463-8003-a306-e053-6294a90a8259 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7e4a84-d2c2-65e5-e053-6394a90a0c72 | 2024-10-08 | Warnings | M012 |
| Cough Drops | CHERRY | United Natural Foods, Inc. | f9f0e853-6997-a49b-e053-6294a90aa4b8 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7fa728-911d-aaf0-e053-6394a90ace31 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f3b84-1e61-eadf-e053-6394a90a9e5c | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f515f-7302-d153-e053-6394a90a0834 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | M012 |
| Mucus Relief Cough and Congestion DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Bryant Ranch Prepack | 8c25285e-e2cd-4e10-af63-5dce8098b615 | 2024-10-08 | Warnings | M012 |
| Severe Throat Sore Drops | MENTHOL | Target Corporation Inc. | 949543d5-5043-ac06-e053-2995a90ab398 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | COUGH DROPS | Target Corporation Inc. | a23ddfa9-19e0-99ee-e053-2a95a90a6856 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY MENTHOL COUGH DROPS | Perrigo Direct, Inc. | fb809c63-94f1-bb7a-e053-6294a90a0a39 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY CHERRY COUGH DROPS | Perrigo Direct, Inc. | fb808dc5-bf63-836c-e053-6294a90a80aa | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY HONEY LEMON | Perrigo Direct Inc. | fb898616-d604-b4c3-e053-6294a90a23bf | 2024-10-07 | Warnings | M012 |
| Natural Herb Cough Drops | MENTHOL HERB | CVS Pharmacy | fcd16063-abca-49a0-e053-6294a90acb26 | 2024-10-07 | Warnings | M012 |
| Lemon Mint Herb Throat Drops | SUGAR FREE LEMON MINT HERB | CVS Pharmacy | fce6b5fa-846d-9911-e053-6294a90afc9b | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | CVS Pharmacy | fcd053e9-92ef-70ba-e053-6294a90aa4dd | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | HONEY LEMON | CVS Pharmacy | f074a64d-dc01-1a37-e053-2995a90adc49 | 2024-10-07 | Warnings | M012 |
| Cough Drops | HONEY LEMON | CVS Pharmacy | f075010d-a07a-5e9d-e053-2995a90a3ca3 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | HONEY LEMON | CVS Pharmacy | fcd053e9-92ee-70ba-e053-6294a90aa4dd | 2024-10-07 | Warnings | M012 |
| Black Cherry Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f2e1a-2593-99e6-e053-2991aa0ad039 | 2024-10-07 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0280-8272-06 | 00280827206 | 6 PACKET in 1 CARTON (0280-8272-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2026-06-01 | No | No | Current |