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 |
|---|---|---|---|---|---|---|
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 9D2RTI9KYH |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Medics Choice Fresh and Soothe | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | KC Pharmaceuticals, Inc. | 3bc03d54-6b31-5921-e063-6294a90af599 | 2025-08-01 | Warnings | PDC6A3C0OX |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Sam's West Inc | 3867a132-1a87-5e08-e063-6294a90a6dc8 | 2025-08-01 | Warnings | 495W7451VQ |
| Good Sense Pain Relief | ACETAMINOPHEN | Proficient Rx LP | b4cb4a62-9ef7-4185-8770-e9a806c2fb3f | 2025-08-01 | Warnings | 362O9ITL9D |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 377248b6-d64d-8dff-e063-6394a90a43f6 | 2025-07-31 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Acetaminophen, Ibuprofen | ACETAMINOPHEN, IBUPROFEN | GLENMARK THERAPEUTICS INC., USA | 57a8dc2b-a3bc-49fa-b605-2330155bdbff | 2025-07-31 | Warnings | 362O9ITL9D |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 3771f778-7ac9-7108-e063-6394a90a1105 | 2025-07-31 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca | 2025-07-31 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Equate Nasal | OXYMETAZOLINE HCL | Wal-Mart Stores Inc | c38a2783-aed9-466d-8976-59d03a792c04 | 2025-07-30 | Warnings | M012 |
| Systane Ultra | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 0537c23a-15f7-be64-1231-a6c93468e9a8 | 2025-07-30 | Warnings | 6DC9Q167V3 |
| Systane | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 1d679d0f-cec2-a644-79cd-079607254bb9 | 2025-07-30 | Warnings | 6DC9Q167V3 |
| Systane Ultra Preservative Free | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 751fb85f-6683-4b0a-a650-324d4a74c5de | 2025-07-30 | Warnings | 6DC9Q167V3 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3b15d2ea-f784-275d-e063-6394a90a800c | 2025-07-29 | Warnings | M012 |
| Pain Relief | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 36ad21a3-6229-e91b-e063-6394a90a7933 | 2025-07-29 | Warnings | 362O9ITL9D |
| Respiratory Relief | GUAIFENESIN | Schwabe North America, Inc | f683041a-4ff9-42a5-9047-a9a3140a8758 | 2025-07-29 | Warnings | M012 495W7451VQ |
| Childrens Robitussin Honey Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | b87f700e-3414-463c-80d4-c3dbca89a488 | 2025-07-29 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | fa88d7b2-6c8e-4893-bd81-ecd4f2aca493 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Systane COMPLETE PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 99b63d62-1cf0-4f28-8760-773917c2538a | 2025-07-29 | Warnings | 6DC9Q167V3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.