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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 447a8753-96bd-676a-e063-6394a90a48f2 | 2026-03-06 | Warnings | M012 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 4c6094b7-c1ef-26a3-e063-6394a90af4cc | 2026-03-06 | Warnings | PDC6A3C0OX |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | 059QF0KO0R |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 51e34704-5e6b-4e80-836c-ddbc24a451b2 | 2026-03-06 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Medi-First Plus Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 20f58b0b-c123-477f-a62c-fa5423e23f93 | 2026-03-06 | Warnings | M012 04JA59TNSJ |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Sportpharm LLC | 7f4e8d37-8c6b-4849-b86c-4335a0bcac1c | 2026-03-06 | Warnings | M012 04JA59TNSJ |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Sportpharm LLC | 2a27da49-23d6-4035-8088-806ee22b98b0 | 2026-03-06 | Warnings | 362O9ITL9D |
| hydrocodone bitartrate and acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Eywa Pharma Inc | 8a201e19-3e47-7e58-e053-2995a90ab1d5 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Artificial Tears | GLYCERIN | Preferred Pharmaceuticals Inc. | dd646c72-8f47-43c6-a734-db0dcc8cd4d1 | 2026-03-06 | Warnings | PDC6A3C0OX |
| Daytime and Nighttime Cold and Flu Kit | DAYTIME AND NIGHTTIME COLD AND FLU KIT | Allegiant Health | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Better Living Brands, LLC | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 2026-03-06 | Warnings | M012 04JA59TNSJ |
| cough dm | DEXTROMETHORPHAN POLISTIREX | HyVee Inc | ce7dafc6-1c23-40d2-94d0-2568298fd7ff | 2026-03-06 | Warnings | 9D2RTI9KYH |
| Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution, Inc. | 87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e | 2026-03-06 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Childrens Pain and Fever | ACETAMINOPHEN | Topco Associates, LLC | 87af092c-99e6-475d-81af-b9fd8fc337d7 | 2026-03-06 | Warnings | 362O9ITL9D |
| RYNEX PE | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | EDWARDS PHARMACEUTICALS, INC. | 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef | 2026-03-05 | Warnings | M012 04JA59TNSJ |
| Oxycodone/APAP | OXYCODONE/APAP | Direct_Rx | e84245ca-957f-e85b-e053-2a95a90a836b | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Dry Eye Relief Sterile Lubricant Eye Drops | GLYCERIN | Similasan Corporation | 4c4cce1c-392e-354d-e063-6294a90a0ca3 | 2026-03-05 | Warnings | PDC6A3C0OX |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 042f9449-4af0-4b15-bb3e-236afeb1e11f | 2026-03-05 | Warnings | M012 04JA59TNSJ |
| Mucus Relief | GUAIFENESIN | Amerisource Bergen | 087a3a0b-8d3f-45ed-8807-0af47b446cac | 2026-03-05 | Warnings | M012 495W7451VQ |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | NUVICARE LLC | 6c4bc7d1-09d9-4311-8457-a1d47ab02a5a | 2026-03-05 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.