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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 770c0e4f-0eed-4b8c-85a5-761b6a84db62 | 2025-12-02 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | WAL-MART STORES INC | a2a7e568-bff8-4818-a31d-7c2efa1859c3 | 2025-12-02 | Warnings | M012 |
| DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET | Lil' Drug Store Products, Inc. | 44fa0193-2a19-bdc1-e063-6394a90a60e8 | 2025-12-02 | Warnings | M012 |
| Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 44fb9958-d771-f4b3-e063-6294a90a9135 | 2025-12-02 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | f1a73da7-0dbb-49bd-857e-7dd6bc11b63c | 2025-12-02 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | ac74be47-30f0-418b-bd07-502feaa9723f | 2025-12-01 | Warnings | M012 |
| Walgreens High Blood Pressure Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN | WALGREENS CO. | bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272 | 2025-12-01 | Warnings | M012 |
| Walgreen High Blood Pressure Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREENS CO. | f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a | 2025-12-01 | Warnings | M012 |
| Walgreens Nighttime Kids Honey Cold Cough Congestion | DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO | c0f317cd-723d-47f2-b600-aaeae6399482 | 2025-12-01 | Warnings | M012 |
| Walgreen Maximum Strength Severe Congestion and cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALGREENS CO. | b4abcb6d-f3e1-4d63-98cf-ff556ec423b6 | 2025-12-01 | Warnings | M012 |
| Walgreens Daytime Childrens | COUGH AND CHEST CONGESTION | WALGREENS CO. | dd99675f-3860-42ef-999c-d9a3746a38c0 | 2025-12-01 | Warnings | M012 |
| Adult Cough plus Chest Congestion DM with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | WALGREEN COMPANY | 5f5af13a-c2a3-4bbe-880e-9c57b36e9234 | 2025-12-01 | Warnings | M012 |
| Walgreens Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREEN COMPANY | b2e08f4d-9753-4767-a8eb-3740dd1034cc | 2025-12-01 | Warnings | M012 |
| WALGREENS Cold Cough and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 1e903034-942e-4c6e-9f96-eb097c266580 | 2025-12-01 | Warnings | M012 |
| Walgreens DAY and NIGHT PACK | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | WALGREEN CO | cb87e57b-ff06-4973-9751-137c7021e272 | 2025-12-01 | Warnings | M012 |
| WALGREEN Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | WALGREENS CO. | b7b1d604-921d-4ae7-93de-dcf690d421b4 | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 235b2866-bbda-7148-e063-6394a90a898f | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 32352109-31dc-8e6f-e063-6294a90a2f92 | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 323347c3-d51a-4976-e063-6294a90a952e | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | WALGREEN COMPANY | 2969ba8f-c477-222a-e063-6394a90af703 | 2025-12-01 | 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 |