NDC 51316-063 - 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
- 51316-063
- Package NDCs from labels
- 51316-063-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-063-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 650 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-063 | 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 |
|---|---|---|---|---|---|---|
| GenCare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pioneer Life Sciences, LLC | 667f6f1b-5179-481c-a131-940c7937aada | 2025-12-26 | Warnings | 362O9ITL9D |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f | 2025-12-26 | Warnings | M012 495W7451VQ |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | Pioneer Life Sciences, LLC | 3ce0f096-906e-47eb-8061-0ac1e9d8ea55 | 2025-12-26 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1194c338-e115-4105-93d8-9ab833c43193 | 2025-12-26 | Warnings | M012 495W7451VQ |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 9c9e558d-d991-4a2e-aa13-37c0b08071e6 | 2025-12-26 | Warnings | M012 495W7451VQ |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1695e7ea-2f83-4d3a-980e-c91be6c1f2a5 | 2025-12-25 | Warnings | M012 495W7451VQ |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | RedPharm Drug | 2c6014de-8901-9d83-e063-6294a90ad37b | 2025-12-25 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | 5162baee-0d63-494e-8046-459437b85348 | 2025-12-25 | Warnings | 04JA59TNSJ |
| Pharbetol | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | 04dbd98f-c74d-43b2-8bda-74f18be7cf6c | 2025-12-24 | Warnings | 362O9ITL9D |
| CETAFEN EXTRA | ACETAMINOPHEN | HART Health | 38db0b09-37f8-4fed-903e-81e89486b39b | 2025-12-24 | Warnings | 362O9ITL9D |
| GUAIFENESIN | GUAIFENESIN | Pharbest Pharmaceuticals, Inc. | 0bf70fb4-d3c8-476d-b864-4eadc697a7d8 | 2025-12-24 | Warnings | M012 495W7451VQ |
| CETAFEN | ACETAMINOPHEN | HART Health | c1162bab-377d-4e17-9417-ccd20d29148b | 2025-12-24 | Warnings | 362O9ITL9D |
| CETAFEN COUGH and COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, , | HART Health | 44da0d8c-4a12-4122-99da-781e2809e1a8 | 2025-12-24 | Warnings | 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Pharbetol Regular strength | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | e0a39957-d918-4125-88f9-0e550b976fa1 | 2025-12-24 | Warnings | 362O9ITL9D |
| PHARBETOL | ACETAMINOPHEN 500MG | Pharbest Pharmaceuticals, Inc. | 27337be9-e279-460e-903e-ae4463099599 | 2025-12-24 | Warnings | 362O9ITL9D |
| PHARBINEX-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Pharbest Pharmaceuticals, Inc. | 8d71db43-da87-45ee-aa4a-7e870bc5016d | 2025-12-24 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 2025-12-23 | Warnings | M012 |
| Tussin | GUAIFENESIN | Discount Drug Mart | 14de3d6d-4eb0-42cf-8941-cb42b3dd5c71 | 2025-12-23 | Warnings | M012 495W7451VQ |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | c8dcba06-a461-4af5-a120-666a63f06ac4 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 920bde5f-4079-45de-aa59-24b00e50cb56 | 2025-12-23 | Warnings | M012 9D2RTI9KYH 362O9ITL9D 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.