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 |
|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Quality Care Products, LLC | e7d36246-9c80-49b6-ad4b-e38c3fd6d068 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Maximum strength Tussnex FM DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Guardian Drug Company | 0bae53e3-9661-4bc6-9fcc-da7fa131b034 | 2024-12-19 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 3fe91e9f-4033-4b48-b51b-7eb67d40fa3a | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Vicks Vaposteam Lavender | CAMPHOR, (-)- | Kaz USA, Inc | 03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9 | 2024-12-19 | Warnings | M012 |
| Refenesen Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Reese Pharmaceutical Co | 6046dc50-f162-4e2d-aa3c-7d27efad477d | 2024-12-18 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Sunmark Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | f94ae469-4c79-4ce9-9a3d-3bdc645be6d9 | 2024-12-18 | Warnings | M012 04JA59TNSJ 495W7451VQ |
| Quality Choice Mucus Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Chain Drug Marketing Association | 1c33a01f-1186-4a19-b639-a9cd49245220 | 2024-12-18 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| HealthMart Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c | 2024-12-18 | Warnings | M012 495W7451VQ |
| DG Health Immediate Release Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | f60a9d1b-7a63-43d3-b843-e1f31cf78873 | 2024-12-18 | Warnings | M012 495W7451VQ |
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80cad8d-da4c-049d-e053-2a95a90ac20e | 2024-12-18 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 8a97c012-6a47-4607-9389-58a4eed17b08 | 2024-12-18 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Orazen Inc | ecddaa3b-e18f-1c74-e053-2995a90ad86a | 2024-12-18 | Warnings | M012 |
| Hemorroidal Cooling gel | PHENYLEPHRINE, WITCH HAZEL | Trifecta Pharmaceuticals Usa Llc | 651c0143-384c-3649-e053-2991aa0a0f28 | 2024-12-18 | Warnings | 04JA59TNSJ |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | c50cc6ad-e8a0-47c1-e053-2a95a90a4de6 | 2024-12-18 | Warnings | 04JA59TNSJ |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | fe18fa61-83f9-8bf9-e053-6294a90a7585 | 2024-12-18 | Warnings | 04JA59TNSJ |
| HemorrhoidalOintment | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI | Trifecta Pharmaceuticals USA LLC | c59dcb2a-392b-670b-e053-2995a90a9682 | 2024-12-18 | Warnings | 04JA59TNSJ |
| Rite Aid Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Rite Aid | dfedbef1-8062-432d-e053-2a95a90a09e9 | 2024-12-18 | Warnings | M012 |
| TheraCare Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Veridian Healthcare | fab95657-d257-e671-e053-6294a90a59e0 | 2024-12-18 | Warnings | 04JA59TNSJ |
| TheraCare Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | f7801843-f96c-710e-e053-6294a90a5086 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief G450 | GUAIFENESIN | Rugby Laboratories | a6aa8cbd-21ff-4f84-b338-c05c2d46e6df | 2024-12-18 | Warnings | M012 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.