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 |
|---|---|---|---|---|---|---|
| RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | c6392ace-c7d1-4450-8b71-4dccc60b4f02 | 2025-09-22 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Guaifenesin 1200 mg | GUAIFENESIN | Dr. Reddy's Laboratories Inc. | 525fda90-134c-f038-c403-eb5ffc1fb1f1 | 2025-09-22 | Warnings | 495W7451VQ |
| UP AND UP MUCUS RELIEF | GUAIFENESIN | Target Corporation | 059cff23-b6a5-40dc-ac4e-9bcb552e9764 | 2025-09-22 | Warnings | 495W7451VQ |
| Sterile Water | WATER | ProPharma Distribution | 3f2ae880-852f-b45d-e063-6394a90aa1cc | 2025-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | H E B | f2f9b930-7b54-46c5-8631-d673a52a9eb4 | 2025-09-19 | Warnings | 362O9ITL9D |
| careone acetaminophen | ACETAMINOPHEN | American Sales Company | 4bb696f6-a47b-4da9-9224-9aeae3e152f3 | 2025-09-19 | Warnings | 362O9ITL9D |
| Childrens Pain Relief | ACETAMINOPHEN | Aurohealth LLC | 49a740ec-8ed4-4c76-b2d0-c13651bafa5e | 2025-09-18 | Warnings | 362O9ITL9D |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Advanced Rx LLC | a7ed4c76-a5b5-44f7-866f-f43790e45c78 | 2025-09-18 | Warnings | 362O9ITL9D |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f12ee8f-d1c6-d73a-e063-6394a90a9199 | 2025-09-18 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3d71d306-893a-e73a-e063-6394a90a0a3b | 2025-09-18 | Warnings | M012 |
| Giltuss D | GILTUSS D | Dextrum Laboratories Inc. | 3f17eefb-b625-b0f2-e063-6294a90afd4d | 2025-09-18 | Warnings | M012 04JA59TNSJ |
| acetaminophen | ACETAMINOPHEN | CVS Pharmacy | fc2d4367-8884-4b76-aa3e-8c35be1ace49 | 2025-09-18 | Warnings | 362O9ITL9D |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Gland Pharma Limited | 2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb | 2025-09-18 | Warnings, Adverse reactions | 04JA59TNSJ |
| Cold and Flu Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b | 2025-09-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | ab02080a-c903-4e4a-a9f3-2b8197ed2f2b | 2025-09-17 | Warnings | 362O9ITL9D |
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 79669930-f744-4bb1-8325-b75951489b64 | 2025-09-17 | Warnings | 362O9ITL9D |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories Inc | 3effaf4b-28c3-6131-e063-6294a90a17ff | 2025-09-17 | Warnings | M012 9D2RTI9KYH |
| AXIV DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 1872e1ff-2e08-c404-e063-6294a90afa14 | 2025-09-17 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| AXIV Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1323a67c-b9c5-038c-e063-6394a90a5e6b | 2025-09-17 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f025ef6-79e7-e833-e063-6294a90ab501 | 2025-09-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.