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 |
|---|---|---|---|---|---|---|
| equaline cough dm | DEXTROMETHORPHAN POLISTIREX | United Natural Foods, Inc. dba UNFI | 16de32bb-1d02-470b-82b6-9b4366e19817 | 2023-07-24 | Warnings | 9D2RTI9KYH |
| Liverex I | GINKGO BILOBA, FEL TAURI, GALLBLADDER (SUIS), HEPAR SUIS), THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, MANGANUM METALLICUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ARSENICUM METALLICUM, SULPHUR, ACONITICUM ACIDUM, CIS, LYCOPODIUM CLAVATUM, NATRUM OXALACETICUM, PHOSPHORUS | Energique, Inc. | 1c23c489-0a43-4736-a30a-0ae02c09fb45 | 2023-07-21 | Warnings | XF417D3PSL |
| Acetaminophen and Ibuprofen (NSAID) | ACETAMINOPHEN AND IBUPROFEN (NSAID) | Wal-Mart Stores Inc. | e7b36e3c-0e8a-1aeb-e053-2995a90a51a4 | 2023-07-17 | Warnings | 362O9ITL9D |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Somerset Therapeutics, LLC | 18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6 | 2023-07-17 | Warnings, Adverse reactions | 04JA59TNSJ |
| Children Pain Relief | CHILDREN PAIN RELIEF | Allegiant Health | 44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096 | 2023-07-17 | Warnings | 362O9ITL9D |
| REFL HS | ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI) | Deseret Biologicals, Inc. | 2fe2d3c1-1829-4a33-be8e-2bad52546f36 | 2023-07-17 | Warnings | XF417D3PSL |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES | Lannett Company, Inc. | 4d62259d-a582-4621-b62e-3d5640cadf7c | 2023-07-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR | BioActive Nutritional | 3382df85-3ec5-4371-830e-4ed345b8f51b | 2023-07-14 | Warnings | 6DC9Q167V3 |
| Dual Action | ACETAMINOPHEN, IBUPROFEN | KROGER COMPANY | ee0ae5e6-388d-0085-e053-2a95a90add8e | 2023-07-12 | Warnings | 362O9ITL9D |
| Pneumotox | TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM, | BioActive Nutritional, Inc. | f8846fb1-92e5-4f8e-b3b3-bc620df90a62 | 2023-07-12 | Warnings | 6DC9Q167V3 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | ee227c52-2cd8-4a06-a2de-a257f1f4732a | 2023-07-11 | Warnings, Adverse reactions | 9D2RTI9KYH |
| New Hanbang Col Cap | ACETAMINOPHEN, CAFFEINE ANHYDROUS, | Lydia Co., Ltd. | e9dbbbcd-9ab7-aa10-e053-2995a90acd24 | 2023-07-10 | Warnings | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | QUAGEN PHARMACEUTICALS LLC | 5f3c7457-6670-4a0d-bdff-c3e0fe91b7c6 | 2023-07-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | BE Pharmaceuticals Inc. | fb069778-d16e-40f9-9c02-5496adfcb5d2 | 2023-07-10 | Warnings, Adverse reactions | 04JA59TNSJ |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM PHENYLACETATE AND SODIUM BENZOATE | MAIA PHARMACEUTICALS, INC | 3529be10-0004-4628-9ca1-67a8acd86b51 | 2023-07-05 | Warnings, Adverse reactions | OJ245FE5EU |
| NOCOLD-S | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Lydia Co., Ltd. | f2e951c9-afac-7e2e-e053-2a95a90a5020 | 2023-07-05 | Warnings | 362O9ITL9D |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Paragon BioTeck, Inc. | a4d3fe20-f063-11e0-ac29-0002a5d5c51b | 2023-06-29 | Warnings, Adverse reactions | 04JA59TNSJ |
| Arthritis Pain | ACETAMINOPHEN | BETTER LIVING BRANDS, LLC | ee84323a-b615-3ec6-e053-2995a90a5a26 | 2023-06-15 | Warnings | 362O9ITL9D |
| 8 Hour Pain Relief | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | c003a34a-bfe5-4298-8a4e-8c75576f5674 | 2023-06-09 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Bryant Ranch Prepack | 90e166ac-8789-4e7a-b5bb-37c475e3a5b0 | 2023-06-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.