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 |
|---|---|---|---|---|---|---|
| careone childrens acetaminophen | ACETAMINOPHEN | American Sales Company | 808f4790-cadd-4285-ae70-25eb547137e2 | 2024-05-07 | Warnings | 362O9ITL9D |
| Severe Cold and Flu Nighttime Honey | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b12f0e-dba7-fd71-e063-6294a90a42c1 | 2024-05-06 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE | Kroger | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2024-05-06 | Warnings | M012 |
| BUTALBITAL and ACETAMINOPHEN | BUTALBITAL AND ACETAMINOPHEN | QUAGEN PHARMACEUTICALS LLC | 1f0dbe62-6aea-4323-ad25-c2211f919253 | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 24813ec6-0111-4782-9182-a2b93501a2bc | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Baxter Healthcare Corporation | 0f67c1bd-915b-4681-88dd-22f5154a80b3 | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Basic Care Childrens Pain and Fever | ACETAMINOPHEN | Amazon.com Services LLC | bf8bed5d-7dd4-492c-98ac-c36ff8be8f41 | 2024-05-06 | Warnings | 362O9ITL9D |
| Basic Care Childrens Pain and Fever | ACETAMINOPHEN | Amazon.com Services LLC | 0c133707-a8b8-4105-82f3-e3855ec19617 | 2024-05-06 | Warnings | 362O9ITL9D |
| leader infants pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | cfbb8553-f3ac-437d-8f63-caa93f257a77 | 2024-05-06 | Warnings | 362O9ITL9D |
| BUTALBITAL and ACETAMINOPHEN | BUTALBITAL AND ACETAMINOPHEN | QUAGEN PHARMACEUTICALS LLC | 2eb09253-7f59-401e-afbc-70bb9600fedf | 2024-05-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| good sense childrens pain and fever | ACETAMINOPHEN | L. Perrigo Company | ab96395c-a19e-40d6-b37e-7f988026fc95 | 2024-05-06 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | WALGREEN CO. | c20d110a-ed5e-aed4-e053-2a95a90a4200 | 2024-05-06 | Warnings | 362O9ITL9D |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 381f4179-0c3b-41f8-927c-c88534ebe06d | 2024-05-06 | Warnings | PDC6A3C0OX |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger | 1014da86-3a0e-136f-e063-6294a90ac931 | 2024-05-04 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Robitussin Honey Maximum Strength Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | eaa10aed-5b1e-48bf-bc05-7a5638851daf | 2024-05-03 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | e35cb719-9e7d-4b2b-81a4-29e147dd74fa | 2024-05-03 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | 09e20842-2b75-43b9-ae5f-3515b35e655b | 2024-05-03 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | f958d8ba-ede9-4b1a-8317-2404b68a9129 | 2024-05-03 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Daytime Nighttime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab57d70-ba54-416f-9f14-b64d2238ea16 | 2024-05-03 | Warnings | M012 |
| Tussin CF Non Drowsy Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | 8ee27600-4f8e-406a-8ea3-eade691448f6 | 2024-05-03 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.