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 |
|---|---|---|---|---|---|---|
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b | 2026-02-17 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | e8a48a00-3533-4c4d-94e1-8a6c6b35a792 | 2026-02-17 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | 1f3efcdd-4976-4aef-a7c6-a5f88d13cb78 | 2026-02-17 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 2026-02-17 | Warnings | M012 |
| Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Chain Drug Marketing Association, Inc. | 3c8f34ad-589a-4872-939c-44ad5e0e47fe | 2026-02-17 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Valu Merchandisers Company | b6144732-99da-4be2-88e0-75f31b323d38 | 2026-02-16 | Warnings, Adverse reactions | M012 |
| topcare day time cold and flu relief multi symptom relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates LLC | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 2026-02-16 | Warnings | M012 |
| Revasol Acetaminophen Suspension | ACETAMINOPHEN | Rnv LLC | 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6 | 2026-02-13 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Topco Associates LLC | 62eed0e8-ba5f-45c2-a543-68b50bcf4b0c | 2026-02-13 | Warnings, Adverse reactions | M012 |
| Revasol Acetaminophen Suspension Dye Free | ACETAMINOPHEN | Rnv LLC | 4abc07b3-6a27-260f-e063-6394a90a28d6 | 2026-02-13 | Warnings | M012 |
| robafen dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Major Pharmaceuticals | 5e19220d-9cf3-4732-b9aa-c09db5d69ce6 | 2026-02-13 | Warnings | M012 |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 686b9456-f16d-4b99-ae58-f607448bed8b | 2026-02-13 | Warnings | M012 |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | 1c3dc4e6-452b-4c84-b53c-426cf9ae8f03 | 2026-02-12 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | af42d3f7-661e-4322-aefe-2b7f9f1010d6 | 2026-02-12 | Warnings | M012 |
| Childrens Giltuss D | CHILDRENS GILTUSS D | Gil Pharmaceutical Corp | cfc2493b-e99e-4b55-98a9-053f95d49844 | 2026-02-12 | Warnings | M012 |
| Giltuss D | GILTUSS D | Gil Pharmaceutical Corp | 298f5457-a7df-474d-9854-68918ee3d330 | 2026-02-12 | Warnings | M012 |
| Vaporizing | CAMPHOR | Walgreen Co. | ef4f95c8-7650-4096-9369-ea8393781bee | 2026-02-12 | Warnings, Adverse reactions | M012 |
| Oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | Prodose, Inc. | 3dce34f0-9f6d-8151-e063-6394a90a1d38 | 2026-02-11 | Warnings | M012 |
| SIGNATURE CARE Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | SAFEWAY | 831da7b6-25c7-4601-b7f1-1800a238b016 | 2026-02-11 | Warnings | M012 |
| Allergy Plus Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d2cf481-622f-4262-b0bd-c38fe5de6721 | 2026-02-11 | 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 |