NDC 51316-063 - 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
- 51316-063
- Package NDCs from labels
- 51316-063-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-063-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 650 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-063 | 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 |
|---|---|---|---|---|---|---|
| Daytime | ACETAMINOPHEN, GUAIFENESIN | CVS HEALTH CORP | 4985c332-6602-fd2d-e063-6394a90accd2 | 2026-03-16 | Warnings | M012 362O9ITL9D 495W7451VQ |
| Daytime Cold and Flu and Nighttime Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 4981bbcd-7178-335f-e063-6394a90ae961 | 2026-03-16 | Warnings | M012 |
| Daytime and Nighttime | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS HEALTH CORP | 43da4211-3bb3-0a8e-e063-6294a90a4fcd | 2026-03-16 | Warnings | M012 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Acella Pharmaceuticals, LLC | 1045e307-f60d-482d-8e06-40e72b84c651 | 2026-03-16 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | H E B | 21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a | 2026-03-16 | Warnings | 362O9ITL9D |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Topco Associates, LLC | eaa98783-5800-4ae9-832f-f4a1fd1790fd | 2026-03-16 | Warnings | 362O9ITL9D |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 2026-03-14 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Mucus Relief | GUAIFENESIN | Grocery Outlet, Inc. | 4466623c-6387-e725-e063-6394a90ad95e | 2026-03-14 | Warnings | 495W7451VQ |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy, Inc | c0b36e4d-3667-58f6-e053-2a95a90afad7 | 2026-03-14 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | a16a85c2-e1fd-4d1a-a650-271ae430eb4f | 2026-03-14 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Kroger Company | ab12c975-2085-4365-9c4b-0be573a260c4 | 2026-03-13 | Warnings | M012 |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Bryant Ranch Prepack | c83366d9-db60-45eb-9c2b-a2c58d45c82c | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Leader Ultra Lubricating Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Cardinal Health | d7f011a2-05ba-47c3-9519-d31602e105c7 | 2026-03-12 | Warnings | 6DC9Q167V3 |
| Leader Restorative Formula Lubricant Eye Drops | PROPYLENE GLYCOL | Cardinal Health | 87fef7e4-e5a8-4aad-94d2-f80f34826d97 | 2026-03-12 | Warnings | 6DC9Q167V3 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 4454d02a-ba49-6c8c-e063-6294a90a4709 | 2026-03-12 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | db0f0164-3cbd-49b0-91ef-2e5218b09c3f | 2026-03-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Allergy Relief Complete | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 88e3e51a-c9a5-43f9-b9d7-97509c607df1 | 2026-03-12 | Warnings | M012 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Amerisource Bergen | c280ac64-920c-4d03-9190-03e0196ed5ef | 2026-03-11 | Warnings | 362O9ITL9D |
| Optimel Manuka Dry Eye Drops | GLYCERIN | Melcare Biomedical Pty Ltd | 88c5e2f0-9f7e-62d1-e053-2995a90a9014 | 2026-03-11 | Warnings | PDC6A3C0OX |
| Optimel Manuka Forte Eye Gel | GLYCERIN | Melcare Biomedical Pty Ltd | 8e0ed6e8-51fc-7c5b-e053-2a95a90a35a9 | 2026-03-11 | Warnings | PDC6A3C0OX |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.