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 |
|---|---|---|---|---|---|---|
| Sinus Congestion | PHENYLEPHRINE HCL | L.N.K. International, Inc. | 81f0276a-99a2-4a57-a0d8-224735aa8c79 | 2026-07-10 | Warnings | M012 04JA59TNSJ |
| SINUS AND HEADACHE | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rite Aid Corporation | efaf3be1-ab39-45f7-a45c-7fea8705c8d0 | 2026-07-10 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Equate Daytime Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | f847d9f2-aa47-4bbe-8f06-19356c637398 | 2026-07-10 | Warnings | M012 |
| INFANTS PAIN AND FEVER | ACETAMINOPHEN | Amazon.com Services LLC | 112076c4-cac2-45ab-9c77-5573edae7180 | 2026-07-10 | Warnings | 362O9ITL9D |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 2a80fba9-5e30-4ec0-bd8e-8957c0654b6c | 2026-07-10 | Warnings | M012 04JA59TNSJ |
| Acetaminophen | ACETAMINOPHEN | Wildman Business Group | 943c8f49-e65e-40bc-b364-3274df4d21a2 | 2026-07-09 | Warnings | 362O9ITL9D |
| Tina Davies IceCream | LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | TINA DAVIES PROFESSIONAL LLC | 6a2b3199-f405-4455-9a02-8885d24eef9c | 2026-07-09 | Warnings | 04JA59TNSJ |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50230cad-3d04-8882-e063-6294a90acf3c | 2026-07-09 | Warnings | M012 |
| Drs pharmacy HEMORRHOIDAL | PHENYLEPHRINE HCL, WITCH HAZEL | OL PHARMA TECH, LLC Drs PHARMACY | 164169b9-0627-9d1a-e063-6294a90ac46d | 2026-07-09 | Warnings | 04JA59TNSJ |
| Sinus Congestion and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rugby Laboratories | fc42e97d-1224-4d29-a55d-1a1885e0bf8f | 2026-07-09 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Walgreen Company | f13fb7e9-50ea-4e2c-a442-38b1b5b315d7 | 2026-07-09 | Warnings | 362O9ITL9D |
| Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 7418d92d-a540-40d6-91d0-b7eb1f87f8ff | 2026-07-08 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Dextromethorphan Hydrobromide and Quinidine Sulphate | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE | Sun Pharmaceutical Industries, Inc. | 92b54ac4-594e-47b8-a4d3-394a29b425f3 | 2026-07-08 | Warnings, Adverse reactions | 9D2RTI9KYH |
| GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN | ACETAMINOPHEN | Cabinet Health P.B.C. | 88884253-5a79-4ac1-b8ce-03966d8b509d | 2026-07-08 | Warnings | 362O9ITL9D |
| Freskaro Ear Drops for Swimmers | FRESKARO EAR DROPS FOR SWIMMERS | Pharma Nobis, LLC | 4f724d85-cd38-41da-e063-6394a90a9fd7 | 2026-07-08 | Warnings | PDC6A3C0OX |
| CAREALL Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | New World Imports, Inc | 561c601f-c2cd-f09c-e063-6294a90adb45 | 2026-07-08 | Warnings | 04JA59TNSJ |
| DG HEALTH COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d | 2026-07-08 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Topco Associates, LLC | bfcabe02-7961-4407-a748-8cd087731398 | 2026-07-08 | Warnings | M012 |
| Aller-chlor | CHLORPHENIRAMINE MALEATE | Rugby Laboratories | 04ca3806-72be-47d4-9fea-5b0dee087683 | 2026-07-08 | Warnings | M012 |
| nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 24c22c9f-0c2f-46dc-850e-ed05f00d3e95 | 2026-07-08 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.