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 |
|---|---|---|---|---|---|---|
| TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | e966b75c-4bb4-4216-8247-baada8f5d759 | 2025-11-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 52327ed0-ea49-4d1c-b928-20ab381be9f2 | 2025-11-11 | Warnings | M012 1043543 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Mucus Relief | GUAIFENESIN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 32f58b4a-3e1b-424f-8296-a9bf9a7d7025 | 2025-11-11 | Warnings | 495W7451VQ |
| TOPCO Childrens Cough Relief | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Topco Associates, LLC | ee0f5627-5104-4990-88ee-2fb46965bc1e | 2025-11-11 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| TOPCARE Childrens Cold and Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates, LLC | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2025-11-11 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| TOPCARE Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2025-11-11 | Warnings | M012 |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | AvKARE | f5bbad36-6a0e-3518-3f12-138ae9f63980 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b1a31-353d-af20-e063-6294a90aa907 | 2025-11-11 | Warnings | 362O9ITL9D |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2426bf76-19bf-4bfd-8f9e-3b348e4b5641 | 2025-11-11 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 4b829607-f5fb-427f-83b5-5b6b9c44ebeb | 2025-11-11 | Warnings | 362O9ITL9D |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b | 2025-11-10 | Warnings | M012 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | d1de0f93-1439-4ee3-b692-56e1a1400682 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Pamprin Max Menstrual Pain Relief | ACETAMINOPHEN AND ASPIRIN AND CAFFEINE | Focus Consumer Healthcare, LLC | 5bd4b935-f003-7df8-e053-2a91aa0a5d79 | 2025-11-10 | Warnings | 362O9ITL9D |
| FARGELIN HEMORRHOIDAL | CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE | MADISON ONE ACME INC | 6844ad63-512d-496a-9458-011894185b0d | 2025-11-10 | Warnings | 04JA59TNSJ |
| Leader 8HR Arthritis Pain Relief | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f6 | 2025-11-10 | Warnings | 362O9ITL9D |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | 93e7ba56-5682-4184-9a93-3b4b972b0e72 | 2025-11-10 | Warnings | 362O9ITL9D |
| TOPCARE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | Topco Associates, LLC | b5e15dd1-6e99-411c-9183-8a4265eae404 | 2025-11-08 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.