NDC 51316-004 - Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 51316-004
- Package NDCs from labels
- 51316-004-45
- Manufacturer
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
- Effective date
- 2025-10-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| CVS 44-004063 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc. | 2025-10-17 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-004-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-004 | SEVERE CONGESTION, COUGH, COLD AND FLU RELIEF MAXIMUM STRENGTH, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] | 4 | Unmatched | 20241017_92c570ff-139f-49ff-a7bd-8a540ecc07c7.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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | f8e5fab4-1212-4c60-a160-9b782f76a198 | 2025-10-03 | Warnings | 362O9ITL9D |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Guaifenesin 400 | GUAIFENESIN TABLETS 400 | InvaTech Pharma Solutions LLC | 40291505-55ca-0759-e063-6394a90acee1 | 2025-10-02 | M012 495W7451VQ | |
| CVS Acetaminophen | ACETAMINOPHEN | CVS Pharmacy | 3d71a0aa-5e03-0bdc-e063-6294a90a6634 | 2025-10-02 | Warnings | 362O9ITL9D |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3dd5b783-5b64-24b5-e063-6394a90ab4ee | 2025-10-02 | Warnings | M012 |
| Acetaminophen and Diphenhydramine citrate | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | InvaTech Pharma Solutions LLC | 403a88fa-e06b-9b6e-e063-6394a90a97b8 | 2025-10-02 | Warnings | M012 362O9ITL9D |
| Equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | United Natural Foods, Inc. dba UNFI | 3053f6d7-0eff-488c-8901-770dcc62af06 | 2025-10-02 | Warnings | M012 9D2RTI9KYH |
| ACETAMINOPHEN | ACETAMINOPHEN | Bryant Ranch Prepack | 8e40f8f1-03c5-444b-8b5e-4532c3146e47 | 2025-10-02 | Warnings | 362O9ITL9D |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | BIONPHARMA INC. | 3ff18027-44fb-50a1-e063-6394a90a2390 | 2025-10-01 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Rompe Pecho CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 401a97af-36ae-4e54-e063-6294a90ab3ee | 2025-10-01 | Warnings | M012 9D2RTI9KYH |
| QUALITY CHOICE Nausea Relief | SODIUM CITRATE DIHYDRATE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | d89e41c1-399a-4157-8d54-bfefe3b1c1cd | 2025-10-01 | Warnings | B22547B95K |
| NyQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | 724d0889-5ba5-3125-e053-2a91aa0a92c1 | 2025-10-01 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| DayQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 724f2833-34bd-6a9e-e053-2991aa0a073d | 2025-10-01 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Cabinet Pain Reliever and Fever Reducer Refill Acetaminophen | ACETAMINOPHEN | Cabinet Health P.B.C. | 2744f082-adfd-4dfc-a87d-ed8c0d84a447 | 2025-10-01 | Warnings | 362O9ITL9D |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | InvaTech Pharma Solutions LLC | b8d360fa-0d80-f6a8-e053-2a95a90a8bd4 | 2025-10-01 | M012 04JA59TNSJ | |
| MUCINEX DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | fcaf1df9-b396-44f2-94ce-e46e80aba66c | 2025-10-01 | Warnings | 9D2RTI9KYH 495W7451VQ |
| LEADER TUSSIN CF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | f4ffe87b-0a62-44ac-b84a-08cf77cda7f5 | 2025-10-01 | Warnings | M012 9D2RTI9KYH 362O9ITL9D 495W7451VQ |
| ACETAMINOPHEN 325 MG | ACETAMINOPHEN | Proficient Rx LP | 6794830a-7856-464d-84be-c8b253cf41ac | 2025-10-01 | Warnings | 362O9ITL9D |
| Xpect Industrial Eye Relief | GLYCERIN, NAPHAZOLINE HCL | Cintas Corporation | a0167d06-7adb-36f4-e053-2a95a90af9ef | 2025-09-30 | Warnings | PDC6A3C0OX |
| Nasal Spray, 1oz, 24/7 Life by 7-Eleven | OXYMETAZOLINE HCL NASAL SOLUTION 0.05% | Lil' Drug Store Products, Inc. | 3e781417-9ffc-f2c9-e063-6294a90a7205 | 2025-09-30 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.