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 |
|---|---|---|---|---|---|---|
| Remodulin | TREPROSTINIL | United Therapeutics Corporation | 6c80bb38-e8db-4138-9f0d-dbbf9c673185 | 2026-07-02 | Warnings, Adverse reactions | 059QF0KO0R |
| 8 HR Arthritis Pain | ACETAMINOPHEN | Dr. Reddy's Laboratories Inc. | 8e780c23-997c-b960-226e-954037baad4b | 2026-07-01 | Warnings | 362O9ITL9D |
| Green Guard Instydose Mucus Relief | GUAIFENESIN | Unifirst First Aid Corporation | 5b21bd13-d649-6570-e063-6394a90a51e9 | 2026-07-01 | Warnings | 495W7451VQ |
| Medique Guaicon Insydose | GUAIFENESIN | Unifirst First Aid Corporation | 5b230d04-3cf2-51e0-e063-6294a90a2498 | 2026-07-01 | Warnings | 495W7451VQ |
| pain relief EXTRA STRENGTH | ACETAMINOPHEN | Meijer Distribution, Inc. | ae84eb7e-a70b-4311-b2dc-ad153047a516 | 2026-07-01 | Warnings | 362O9ITL9D |
| TUSSIN CF SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 01d6c897-619d-4a6d-8950-4d6d32346b9b | 2026-07-01 | Warnings | M012 9D2RTI9KYH 362O9ITL9D 495W7451VQ |
| NITE TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 161c34b4-3cd2-40b4-b13e-ad980ad4249c | 2026-07-01 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 437cd589-f5da-4390-b178-609d4537eaab | 2026-07-01 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | d36f86e2-fe0f-4b74-a5bf-b23082d72da2 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Salado Sales, Inc. | ca21d576-be3c-495d-9dbd-ed514bf65da7 | 2026-07-01 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | ac6b4a26-7ead-458e-8a3d-591aa0709343 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Meijer Distribution Inc | 4e08a7cb-3894-84c3-e063-6394a90a0b42 | 2026-06-30 | Warnings | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | cb05d615-918d-8104-e053-2995a90aa96b | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Wal-Mart Stores Inc | 9b1201af-c802-4e19-b192-bbbf34367db4 | 2026-06-30 | Warnings | 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | fc841cba-8f4f-407b-97de-0422977515bd | 2026-06-30 | Warnings | 362O9ITL9D |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | United Natural Foods, Inc. dba UNFI | b6ff2b34-51ee-41bc-8b7d-7520ade0bf36 | 2026-06-30 | Warnings | 362O9ITL9D |
| Mucinex | GUAIFENESIN | Bryant Ranch Prepack | a898b584-e17e-45c4-8a28-9f686b95dca0 | 2026-06-29 | Warnings | 495W7451VQ |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 25c03c47-0057-41b6-a530-c6ea85eb750f | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 9167a80e-fcf0-4b64-97e6-8a8ac566f134 | 2026-06-29 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | DISCOUNT DRUG MART | 55653790-9400-e63b-e063-6394a90ae5f7 | 2026-06-29 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.