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 Nighttime Ultra Concentrated Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0c0cf76f-2dd3-45ef-e063-6394a90a9fef | 2024-08-22 | Warnings | M012 |
| Day Cold and Flu and Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | TARGET CORPORATION | 08ee56d1-b11d-3e36-e063-6294a90acd5f | 2024-08-22 | Warnings | M012 |
| Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE | TARGET CORPORATION | 0fc523ce-55a7-6384-e063-6394a90aad3f | 2024-08-22 | Warnings | M012 |
| Dual Action | ACETAMINOPHEN, IBUPROFEN | BETTER LIVING BRANDS, LLC | f2c096bb-cfed-bfa4-e053-2995a90af2cb | 2024-08-22 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| pain reliever | ACETAMINOPHEN | Walgreen Company | 8255900a-2d58-4261-8df7-f28319883570 | 2024-08-21 | Warnings | 362O9ITL9D |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Dr. Reddy's Labratories Inc. | 69df02fa-c842-48dc-7ac6-5967b7dc30de | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 9698729e-08d0-483c-b157-5a4061d97065 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreens | 8045aef9-22bc-4146-b494-dbb1ffef06df | 2024-08-19 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| butalbital and acetaminophen | BUTALBITAL AND ACETAMINOPHEN | Dr. Reddy's Labratories Inc. | 42d808d6-d8d4-22f5-ac2f-0f0d1d71686a | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6dde2f85-e329-4bca-832d-d45786df9f52 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | Kroger Company | d965eba0-b268-41b2-8e02-5f6d769a44d7 | 2024-08-18 | Warnings | 362O9ITL9D |
| equate pain and fever childrens | ACETAMINOPHEN | Wal-Mart Stores Inc | ea68d735-c677-4280-a3a3-ae3eb5ff7462 | 2024-08-17 | Warnings | 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 5a2053d4-9c0d-4613-9cf5-0067173f3730 | 2024-08-16 | Warnings | M012 |
| childrens pain and fever | ACETAMINOPHEN | CVS Pharmacy | fac408f0-ebb6-4c72-88ee-2ba85867859c | 2024-08-16 | Warnings | 362O9ITL9D |
| QUALITY CHOICE Long Acting Cough Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Marketing Association, Inc. | f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c | 2024-08-16 | Warnings | M012 9D2RTI9KYH |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Padagis Israel Pharmaceuticals Ltd | 458594e1-8d99-4de3-8923-2fd8ce2fc406 | 2024-08-16 | Warnings | M012 |
| hemorrhoidal relief | COCOA BUTTER, PHENYLEPHRINE HCL | Rite Aid Corporation | ddafbdca-32c2-49c1-83d3-35b4155958c9 | 2024-08-15 | Warnings | 04JA59TNSJ |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 54e0d57e-1f48-45e2-86b3-0e50775996f4 | 2024-08-15 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.