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 |
|---|---|---|---|---|---|---|
| Hemorrhoidal cocoa butter | HEMORRHOIDAL | NeilMed Pharmaceuticals Inc. | 03b159b0-b960-b38d-e063-6394a90a9462 | 2025-01-17 | Warnings | 04JA59TNSJ |
| Glycerin Laxative | GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF | NeilMed Pharmaceuticals Inc. | 03b4be69-6488-76be-e063-6394a90a7edf | 2025-01-17 | Warnings | PDC6A3C0OX |
| Percogesic Original Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Medtech Products Inc. | 529974c2-0121-4892-8e47-c2c447581091 | 2025-01-17 | Warnings | 362O9ITL9D |
| Kroger DayTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Co. | 2499210b-c162-76b9-e063-6294a90adbc3 | 2025-01-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | b9df47cf-f999-49d8-95b9-374c0539b6a1 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Childrens Multi Symptom Cold Very Berry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS | 2a849ae9-338f-4642-e063-6394a90a1ca4 | 2025-01-17 | Warnings | M012 1043543 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Little Remedies Childrens Fever Pain Reliever | ACETAMINOPHEN | Medtech Products Inc. | e1e44c85-d10c-4997-8f85-064cda7906eb | 2025-01-17 | Warnings | 362O9ITL9D |
| Kroger NightTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Co. | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2025-01-17 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Dye Free Childrens Acetaminophen | ACETAMINOPHEN | Precision Dose Inc. | 5cc698fa-0841-4851-ae21-0aac8b40eb0a | 2025-01-16 | Warnings | 362O9ITL9D |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Everpharm LLC | d7aaf874-69ac-49cf-93be-6d4a38b9a557 | 2025-01-16 | Warnings | M012 |
| Acetaminophen | ACETAMINOPHEN | RITE AID | d1f18c32-c043-7c97-e053-2a95a90a203e | 2025-01-16 | Warnings | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | SUNRISE PHARMACEUTICAL, INC | ee7630f8-f4b8-4eb0-b34d-d908567030c4 | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Children Pain and Fever Reliever | ACETAMINOPHEN | Target Corporation | 0dd643a4-3cbc-423d-95b4-ba373b09d895 | 2025-01-16 | Warnings | 362O9ITL9D |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 204a7fc4-142d-45fd-8a77-0612857132be | 2025-01-16 | Warnings | M012 9D2RTI9KYH |
| daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | df31056b-d0eb-4094-98d9-3d444210d50d | 2025-01-16 | Warnings | M012 |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Reliable 1 Laboratories LLC | 28dd9baa-43bd-b60a-e063-6394a90a8cf7 | 2025-01-15 | Warnings | M012 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 2651bf11-4d66-43ba-e054-00144ff88e88 | 2025-01-15 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN 325 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 25626b46-78f8-7226-e054-00144ff8d46c | 2025-01-15 | Warnings | 362O9ITL9D |
| Guaifenesin | GUAIFENESIN | Reliable 1 Laboratories LLC | ae469d4f-91c4-cff0-e053-2995a90a0497 | 2025-01-15 | Warnings | M012 495W7451VQ |
| Diphenhydramine HCL 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32f58cb3-941f-263b-e054-00144ff8d46c | 2025-01-15 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.