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 |
|---|---|---|---|---|---|---|
| Acetaminophen Extra Strength | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | f3feca65-adc1-469f-bef6-12c860599abe | 2026-05-04 | Warnings | 362O9ITL9D |
| Sanatos Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 3dd3ed85-0c0a-8390-e063-6294a90a668e | 2026-05-04 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | KVK-Tech, Inc. | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Good Sense Daytime non drowsy cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 0122cd34-5817-4af5-a51a-8d176dee0a30 | 2026-05-04 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | d810a6a9-6112-4e9d-a396-36084b7e110e | 2026-05-04 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Childrens Pain and Fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 4dda3534-4e83-447b-be75-33dadce06c47 | 2026-05-04 | Warnings | 362O9ITL9D |
| COUGH DM | DEXTROMETHORPHAN POLISTIREX | Safeway | 58dab2f1-27b5-4522-bdc6-b710f20802eb | 2026-05-04 | Warnings | 9D2RTI9KYH |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 2026-05-01 | Warnings | M012 |
| Tylenol PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 2026-05-01 | Warnings | 362O9ITL9D |
| Tylenol Extra Strength | ACETAMINOPHEN | Savings Distributors LLC | 8ed90757-833e-f4d9-e053-2995a90a29db | 2026-05-01 | Warnings | 362O9ITL9D |
| Tylenol Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 2026-05-01 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 2026-05-01 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | 6980bfc5-15e4-48ec-9346-6f09f8f78900 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Sinus Pressure and Congestion Relief PE Maximum Strength | PHENYLEPHRINE HCL | Rite Aid Corporation | fccea3c5-42af-4939-82bc-d9409b75f91f | 2026-05-01 | Warnings | M012 04JA59TNSJ |
| Mucus Relief | GUAIFENESIN | Harris Teeter, LLC | f7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c | 2026-05-01 | Warnings | 495W7451VQ |
| Night Time Cold and Flu original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | cfaf4b3d-fab4-424d-adbe-aaedca58912d | 2026-04-30 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | 21e7d323-5b78-43aa-b0fc-34c2a864ab9a | 2026-04-30 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | SpecGx LLC | d621b526-4d9a-48a9-9a3e-d29d6aea2f31 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | ec0b5f4b-b58c-445f-acf1-c7ce301bba64 | 2026-04-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | 098428ae-e87d-4c29-8f02-1590530da58e | 2026-04-29 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.