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 |
|---|---|---|---|---|---|---|
| Coricidin HBP Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE | A-S Medication Solutions | ffcae882-0b19-4219-bbee-a175c63d79c8 | 2024-03-11 | Warnings | M012 9D2RTI9KYH |
| Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 18dcede2-5a38-40fa-93fe-48acdd6a7cf1 | 2024-03-08 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | d4ce06aa-776f-45e4-a1a6-9cf13797048f | 2024-03-08 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 14e38ef0-a5e7-4df7-824f-f27bef664d25 | 2024-03-08 | Warnings | M012 362O9ITL9D |
| Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 68d3e88a-d1be-410b-92a1-863903b3aa61 | 2024-03-08 | Warnings | M012 |
| Theraflu Severe Cold relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 0d3b1bea-e2ca-4e07-8ae5-60627d230c96 | 2024-03-08 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Theraflu PowerPods Daytime Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | e655c33c-c319-41d9-ae55-cf747242cd10 | 2024-03-08 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | adf33520-4689-4de2-b9d8-c201518e9d26 | 2024-03-08 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Strive Pharmaceuticals Inc. | 78c12459-3b27-4ed0-943d-520794eb438d | 2024-03-07 | Warnings | 362O9ITL9D |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7 | 2024-03-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 2024-03-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 62f7fcb9-e31a-4634-b1c2-44a9567e3a61 | 2024-03-07 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Theraflu ExpressMax Severe Cold and Flu Caplets | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 8e22f6bc-33ce-4bb0-99be-7947aa21f60e | 2024-03-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Theraflu ExpressMax Severe Cold and Flu Syrup | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 | 2024-03-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 4c6025ff-4982-4408-b077-75dd5f5b65b2 | 2024-03-07 | Warnings | M012 04JA59TNSJ |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | 423fd5e6-5d90-4539-81e0-0ae23881ee3a | 2024-03-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 917df706-1982-4240-9f56-42d426b76cc5 | 2024-03-06 | Warnings | M012 |
| Chemtox | BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOL | Deseret Biologicals, Inc. | 91f52c95-f36d-4754-8570-f81ed8d36180 | 2024-03-06 | Warnings | 506T60A25R |
| Pain Reliever fever Reducer Extra Strength | ACETAMINOPHEN | CVS Pharmacy | 7b5263ad-01b7-4fc5-9384-4da8efe89e35 | 2024-03-06 | Warnings | 362O9ITL9D |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 21a29998-29d6-4a36-a370-291d23bfb197 | 2024-03-05 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.