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 | Redpharm drug | 1535f903-8bd0-c09e-e063-6294a90a4d4d | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen and Codeine | ACETAMINOPHEN AND CODEINE | RedPharm Drug, Inc. | a35b4ba3-43c0-73c8-e053-2a95a90af5b5 | 2025-04-09 | Boxed warning, Warnings | 362O9ITL9D |
| Advil Allergy and Congestion Relief | CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a6cc97d8-252a-4527-a470-6d9e356342fd | 2025-04-09 | Warnings | 04JA59TNSJ |
| Bio Co Enzyme Phase | ACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, | Deseret Biologicals, Inc. | 6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db | 2025-04-08 | Warnings | XF417D3PSL |
| Foster and Thrive Pain Reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 0a7d82f8-7615-4cef-b245-94b186f3c8fa | 2025-04-07 | Warnings | 362O9ITL9D |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Xttrium Laboratories, Inc | 30c9d769-bc74-04d2-e063-6294a90a665a | 2025-04-07 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Direct_Rx | e4e27022-581e-ba8c-e053-2a95a90a1ae4 | 2025-04-07 | Warnings, Adverse reactions | 362O9ITL9D |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Aurohealth LLC | 02d2a5a6-36bb-45b5-aba7-779615b276ed | 2025-04-05 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Acetaminophen | ACETAMINOPHEN | Gland Pharma Limited | db5d4cf8-762a-4111-971e-91c704bc3643 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN 500MG | CVS Pharmacy, Inc. | 1fde6487-6682-99a3-e063-6294a90a3670 | 2025-04-04 | Warnings | 362O9ITL9D |
| CVS Wild Cherry Throat Drop | PECTIN | CVS | 31f4b641-e9c0-786e-e063-6394a90aa253 | 2025-04-04 | Warnings | M012 |
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN AND IBUPROFEN | Dr. Reddy's Labortories Inc | 3e65c8a3-498e-1a2a-bb76-18e28ae2c73c | 2025-04-04 | Warnings | 362O9ITL9D |
| Nighttime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS | WALGREENS | 2be0a699-e6ad-ef56-e063-6394a90aaca5 | 2025-04-03 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 44fb27d3-5125-4511-84d2-76555bc46e66 | 2025-04-03 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Eye Wash | WATER | CMC Group Inc. | 6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561 | 2025-04-02 | Warnings | 059QF0KO0R |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals, Inc. | 31d24067-3c25-0f1a-e063-6394a90a9f1d | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| dextromethorphan polistirex extended release | DEXTROMETHORPHAN POLISTIREX | Bryant Ranch Prepack | bd415342-90e1-411b-b6c9-652e9532c611 | 2025-04-02 | Warnings | 9D2RTI9KYH |
| Childrens Acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | bdc466c9-d9ae-4293-b7ea-46fb517661c6 | 2025-04-01 | Warnings | 362O9ITL9D |
| Guaifenesin | GUAIFENESIN | KESIN PHARMA CORPORATION | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 2025-04-01 | Warnings | M012 495W7451VQ |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Alcon Laboratories, Inc. | cacbb3fd-1c03-4523-a1bf-0ccc4be102ef | 2025-04-01 | Warnings, Adverse reactions | 04JA59TNSJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.