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 |
|---|---|---|---|---|---|---|
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 04JA59TNSJ |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 495W7451VQ |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| equaline childrens acetaminophen | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | 1e0cbb47-08f6-4afb-ad5a-6ce1b262ab97 | 2024-09-19 | Warnings | 362O9ITL9D |
| TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of Blood | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 02015040-9b71-4dbe-8f8d-e0d0951e8f93 | 2024-09-19 | Warnings | XF417D3PSL B22547B95K |
| DoloDent Toothache For adults | ACETAMINOPHEN, CAFFEINE | Pharmadel LLC | 1e7a0c06-ad3c-b94f-e063-6394a90abab1 | 2024-09-19 | Warnings | 362O9ITL9D |
| foster and thrive childrens pain and fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 0a4b10e3-29df-40a5-a3fa-0e9beeadfbb4 | 2024-09-19 | Warnings | 362O9ITL9D |
| good sense childrens pain and fever | ACETAMINOPHEN | L. Perrigo Company | 61a88a72-cf4f-4ec9-bc24-e110adfb98ba | 2024-09-19 | Warnings | 362O9ITL9D |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 04JA59TNSJ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 226765e9-a6b1-22b6-e063-6394a90a364e | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 5791c1c7-f614-4940-a45a-6291742e1e22 | 2024-09-17 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 2affd44d-2125-4a1f-919c-c082e7644ea8 | 2024-09-17 | Warnings | M012 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 223fe2b4-aa12-81fd-e063-6394a90a6c08 | 2024-09-16 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| childrens pain and fever | ACETAMINOPHEN | Walgreen Company | 550c4229-c3a3-442c-a9ed-2d04cd4bad51 | 2024-09-14 | Warnings | 362O9ITL9D |
| DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE | Advanced Rx LLC | fa1a4d86-87bb-0c50-e053-6394a90a56e2 | 2024-09-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Advanced Rx LLC | fa1b60b1-49cb-1211-e053-6394a90a0a46 | 2024-09-13 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 8db7df1c-46b5-49bd-9002-50b12d58001a | 2024-09-13 | Warnings | M012 04JA59TNSJ |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | Breckenridge Pharmaceutical, Inc. | d74db417-d2de-495b-bb75-46a83745603d | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.