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 |
|---|---|---|---|---|---|---|
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | e2c35fae-9dd6-51f2-e053-2995a90a1e9e | 2024-10-17 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Cough and Cold XL3 Xtra | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 2024-10-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Pain Relief Extra Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | a2186895-944b-48cb-b3c2-eac208866c34 | 2024-10-17 | Warnings | 362O9ITL9D |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | MIDWAY IMPORTING INC. | 58252f15-485c-3061-e053-2a91aa0a2320 | 2024-10-17 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Midway Importing, Inc. | e41b9beb-e274-5c02-e053-2995a90ad0f8 | 2024-10-17 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 38e70a28-eff2-4a48-b829-8cd68e80beef | 2024-10-17 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Midway Importing Inc. | c2c8bd26-bbf1-c2e6-e053-2995a90a86a7 | 2024-10-17 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Pain Relief Regular Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | 6a5d43c8-f4b7-4447-b2e1-53eb12208ef0 | 2024-10-17 | Warnings | 362O9ITL9D |
| Pain Relief Extra Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | 9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e | 2024-10-17 | Warnings | 362O9ITL9D |
| Antiflu Des Cough and Flu | ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE | Productos Farmaceuticos, S.A. de C.V. | dcf3897a-a793-6df7-e053-2995a90a25f8 | 2024-10-17 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Chemtox | TRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, | BioActive Nutritional, Inc. | 9aa060f1-f8f6-46e6-a7d0-bd46a73f2676 | 2024-10-17 | Warnings | 506T60A25R |
| hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | H E B | 1435432d-5ff2-468b-808d-fb0c99a0717b | 2024-10-17 | Warnings | 04JA59TNSJ |
| Acetaminophen | ACETAMINOPHEN | Rising Pharma Holdings, Inc. | 319ede76-110e-4902-a931-39a6d3b8c731 | 2024-10-17 | Warnings | 362O9ITL9D |
| hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Meijer Distribution Inc | 14319ba4-3bce-497c-a380-65bd24defc5d | 2024-10-17 | Warnings | 04JA59TNSJ |
| equate hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 581dd76f-d052-4448-8139-9a2e31891b25 | 2024-10-17 | Warnings | 04JA59TNSJ |
| Acetaminophen Extra Strength | ACETAMINOPHEN | FSA Store Inc. | ec6add55-f4a3-7818-e053-2a95a90aee04 | 2024-10-16 | Warnings | 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | ec6aef90-ece1-4fe6-e053-2995a90a9310 | 2024-10-16 | Warnings | M012 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | f4322f34-ac19-371e-e053-2a95a90ac864 | 2024-10-16 | Warnings | 362O9ITL9D |
| Tukol MAX ACTION Cold, Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | c8eebe64-00bf-436d-a9fc-1623401bebfa | 2024-10-16 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 850b5ad8-8774-413c-ae38-022215a94f95 | 2024-10-16 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.