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 |
|---|---|---|---|---|---|---|
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 176be362-5237-edd8-e063-6294a90a4aef | 2024-06-01 | Warnings | M012 9D2RTI9KYH |
| Dimetapp Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 179115ad-d610-99b2-e063-6294a90ae711 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 179259a9-231e-df03-e063-6294a90a145e | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough | BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Healthcare | 1820e7c7-bc11-9061-e063-6394a90ae581 | 2024-06-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 2024-06-01 | Warnings | M012 |
| CareOne Infants Acetaminophen | ACETAMINOPHEN | American Sales Company | 0a28a4f1-d947-489b-be28-36ba10b581cf | 2024-06-01 | Warnings | 362O9ITL9D |
| Sterile Water | WATER | Becton Dickinson and Company | 6e43c5a3-dad2-49ed-b500-964cb4563cc9 | 2024-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Maximum Strength Nasal Decongestant | OXYMETAZOLINE SPRAY | CVS Health | df1f8bda-7bf3-4755-9169-f2a81d824cbe | 2024-05-31 | Warnings | M012 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 4a873428-bb5a-4e48-9185-2a27f289110d | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88d05136-7b04-4b25-af1c-6bc72fdbcbd7 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | a78d29ed-019b-4014-ae6f-c60c75d19c89 | 2024-05-31 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 6594c117-6ffc-4bda-8bbf-e91c810f2c3f | 2024-05-31 | Warnings | M012 |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 96173ce4-4836-43ae-9797-5246f830643a | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 3791abd3-fcdf-4c8d-b46d-db6e5c805770 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | 0c85d1b8-ea42-421d-a305-4d338b47150f | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | 77fb237f-28b5-486b-b9ef-cb324d5cc0bd | 2024-05-30 | Warnings | 362O9ITL9D |
| MUCINEX | GUAIFENESIN | A-S Medication Solutions | 69c83a02-377f-4c6c-96f6-557b3a3d8ca1 | 2024-05-29 | Warnings | 495W7451VQ |
| Excedrin Migraine | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | A-S Medication Solutions | d012ed1d-b256-48ec-b988-f226c2c5ae9e | 2024-05-29 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | b5053cf5-209d-4106-afc2-cf9af85f4a69 | 2024-05-29 | Warnings | 362O9ITL9D |
| Maximum Strength Mucus Relief | GUAIFENESIN | KROGER COMPANY | 100ff8e2-88ed-0e8c-e063-6294a90a5716 | 2024-05-25 | Warnings | 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.