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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCL | RB Health (US) LLC | 4cc490a6-a27a-a25b-e063-6294a90a3a95 | 2026-03-11 | Warnings | M012 2173667 |
| Mucus Relief Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | 6207ef50-4f28-4dbc-9a52-f44dd53d2a4f | 2026-03-11 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c17a10a3-6b8f-4734-8f00-1f4c5c729725 | 2026-03-11 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | ba6d69ff-b392-4f21-b3d7-00d8ec5dee32 | 2026-03-11 | Warnings | M012 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | 66e184cd-fa32-431f-b843-9c4bea12593b | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 67428f4b-28be-4682-a9a9-781bf85089ff | 2026-03-10 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HEB | 40091b98-b4c7-4a3b-e063-6294a90abd5d | 2026-03-10 | Warnings | M012 |
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS | Sun Pharmaceutical Industries, Inc. | 2a31a975-72f9-2a16-e063-6394a90a8149 | 2026-03-10 | Warnings | 362O9ITL9D |
| Allergy | CHLORPHENIRAMINE MALEATE | United Natural Foods, Inc. dba UNFI | 0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da | 2026-03-10 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Topco Associates, LLC | 35305aa9-4fc1-4cda-b6f0-89df64f9eeff | 2026-03-10 | Warnings | M012 |
| Acetaminophen | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d79828d8-9279-4ae9-8872-aeca641be5d9 | 2026-03-10 | Warnings | 362O9ITL9D |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 03332596-2c37-4771-b13b-ab766e616866 | 2026-03-10 | Warnings | M012 |
| Sinus Pressure and Congestion Relief Maximum Strength | PSEUDOEPHEDRINE HCL | Rite Aid Corporation | d86140ab-1117-4d14-a380-f5cc375775a1 | 2026-03-10 | Warnings | M012 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 806a981f-85ff-4e58-8ff0-7ab02ed2e5c1 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | 4c9cca86-41bf-1635-e063-6294a90a17fb | 2026-03-09 | Warnings | M012 |
| sinus pressure and pain and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Target Corporation | 488588f3-62d3-4248-937a-1c200792b5f1 | 2026-03-09 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| foster and thrive childrens pain and fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | e495a27e-eb64-4c42-8942-43bab9918172 | 2026-03-07 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Major Pharmaceuticals | 0ca49c3c-f2cb-40e3-a7d5-5f48eca59016 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY | 67a190c3-7de0-4f57-be94-d6b8285e1220 | 2026-03-06 | Warnings | 362O9ITL9D |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 31778652-e60e-4098-8e90-3e4f56b5800c | 2026-03-06 | Warnings | PDC6A3C0OX |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.