NIGHTTIME SEVERE COLD AND FLU
- Product NDC
- 51316-477
- 11-digit product format
- 513160477
- Labeler code
- 51316
- Product ID
- 51316-477_7deea588-0213-4592-b56f-6db418bf8ff2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-14
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- 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
- NIGHTTIME SEVERE COLD AND FLU
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
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 |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d1115a55-35cd-4f20-8872-f42983a5ebcd | 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 |
|---|---|---|---|---|---|---|
| Dristan 12 hr | OXYMETAZOLINE HYDROCHLORIDE | Foundation Consumer Brands | 522876fe-a412-4ca8-bfad-a313e3cbc1af | 2025-10-24 | Warnings | M012 |
| Dimetapp Multi-Symptom Cold and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 178fe95b-e1ed-43b2-e063-6294a90a7a78 | 2025-10-24 | Warnings | M012 |
| Menthol Drops Dollar General Severe 45ct | MENTHOL | Dollar General Corporation | c831d3d9-b910-40e6-bfdf-defe6850614d | 2025-10-24 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 7d2f3292-bb73-41dc-9729-edb83670be1b | 2025-10-24 | Warnings | M012 |
| Freegells Cough Drops Menthol 30ct | MENTHOL | R.L. ALBERT & SON, INC | b174e57c-4e4f-4842-b8f2-f1b067764a68 | 2025-10-24 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 17640528-c1f7-4881-ba86-bb3f488a952c | 2025-10-24 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 33e259d6-b065-a677-e063-6394a90ab314 | 2025-10-23 | Warnings | M012 |
| Severe Nighttime Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 2025-10-23 | Warnings | M012 |
| Rycontuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories, Inc | 41afb883-1158-9764-e063-6294a90a1712 | 2025-10-21 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE | CVS Pharmacy, Inc | 1532ee21-e114-ded7-e063-6294a90ab025 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 1538bf63-d020-3ba2-e063-6294a90aecc5 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 389230e5-775e-5b0d-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 312ce620-4841-7488-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Method Pharmaceuticals, LLC | 5a60c923-8bb7-427f-9636-08ed5474f71b | 2025-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 97ed70a0-b692-4c12-90d6-72b3c87e554c | 2025-10-21 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 311e2b6b-21cb-4b4c-a78d-a0732d29602f | 2025-10-21 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 13910ea1-37dd-43bb-9fe8-e843f59201b7 | 2025-10-21 | Warnings | M012 |
| SudoGest | PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | d46577aa-7fd7-2130-6ed6-4b3f7562491f | 2025-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | d6f185b6-8538-4eac-98da-83760c34b488 | 2025-10-20 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-477-40 | 51316047740 | 355 mL in 1 BOTTLE (51316-477-40) | 355 ml | 2026-07-14 | No | No | Current |