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 |
|---|---|---|---|---|---|---|
| Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51a45db8-2bee-6fd0-e063-6394a90ab587 | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 19da539e-7b57-41d7-aad5-fc89a6705e20 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 182222b5-a852-4dbe-b05f-a41d89806021 | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Maximum Strength Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8a790eeb-7d7d-4a94-9103-6ed09c04d596 | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | dbdafbb4-f3c9-4042-b867-db4d06dc3d61 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3 | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 29571047-4c4b-44ca-8726-57c28308e8cf | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 75c6b92f-219f-4740-bb72-c02a927a21ff | 2026-05-12 | Warnings | M012 |
| Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | c746953f-4b7d-4e2a-9b85-96bd6901f517 | 2026-05-12 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | cea08797-1d53-4434-be1a-144f2ded5f9d | 2026-05-12 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 2026-05-12 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a401eb92-60b6-427d-a677-29371a3150be | 2026-05-12 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7c18e95-8d7b-4550-9a20-fc704a114adb | 2026-05-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 66543190-1d3d-4259-ae73-d366ecbf9e52 | 2026-05-12 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| basic care daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 612719a9-fa2e-4c40-8f35-a399aeaafecc | 2026-05-12 | Warnings | M012 |
| Menstrual Relief | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | CVS Pharmacy | 289ec101-c9a3-45f1-b2cd-8eaf8e580130 | 2026-05-12 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | A-S Medication Solutions | c445c6bb-69a8-492e-b100-ce942707f203 | 2026-05-12 | Warnings | 362O9ITL9D |
| PMS Relief Maximum Strength | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | CVS Pharmacy | 760ee367-0625-48d7-98a7-84c69389ad3e | 2026-05-12 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.