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 |
|---|---|---|---|---|---|---|
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 17a07d2d-f2da-4e51-9a77-6f0c174987bb | 2024-01-31 | Warnings | M012 1043543 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| butalbital, acetaminophen and caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 6a593fc7-49b0-4910-8a0c-5e718e5ff45b | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Sterile Water | WATER | A-S Medication Solutions | dba87371-31d2-47c2-ab83-89aabce4b184 | 2024-01-31 | Warnings, Adverse reactions | 059QF0KO0R |
| THERAFLU POWERPODS NIGHTTIME SEVERE COLD | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 39f9feef-4bf2-4f10-9fff-22bbb1d8a471 | 2024-01-30 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 102bdcde-cb90-f248-e063-6394a90aac79 | 2024-01-30 | Warnings | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Seton Pharmaceuticals LLC | 3c5cefe3-c84e-4380-97f3-78e3fe92543a | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Haleon US Holdings LLC | 61802b27-c9ec-4386-9d44-45e8b1e558b7 | 2024-01-28 | Warnings | 362O9ITL9D |
| Theraflu Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Haleon US Holdings LLC | c0689223-5c90-4dbc-bbfa-f94e267504c3 | 2024-01-28 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Excedrin Migraine Geltabs | ACETAMINOPHEN, ASPRIN, CAFFEINE | Haleon US Holdings LLC | cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8 | 2024-01-28 | Warnings | 362O9ITL9D |
| THERAFLU MULTI-SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | a4c56ca0-7785-404b-996d-137cc135f270 | 2024-01-28 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| THERAFLU NIGHTTIME SEVERE COLD AND COUGH | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 5f7f6f70-0f36-4541-89f2-d953259cdb1e | 2024-01-28 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| AGRIFEN | ACETAMINOPHEN, ASPIRIN, CAFFEINE | OPMX LLC | 0fde22da-cdfc-36cc-e063-6294a90a3885 | 2024-01-26 | Warnings | 362O9ITL9D |
| DOLODOL | ACETAMINOPHEN, ASPIRIN, CAFFEINE | OPMX LLC | e80536f1-92cc-5bb3-e053-2995a90a9540 | 2024-01-26 | Warnings | 362O9ITL9D |
| No More Products | GLYCERIN, KAOLIN, CALAMINE, MENTHOL | Sarati International, Inc | 102e7dbb-06dc-f4d1-e063-6394a90aa3eb | 2024-01-26 | Warnings | PDC6A3C0OX |
| Pranicura 5 | GLYCERIN, KAOLIN, CALAMINE, MENTHOL | Sarati International, Inc. | 0fe10710-ac59-4fc5-e063-6294a90a48fc | 2024-01-26 | Warnings | PDC6A3C0OX |
| RESFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | 0e9c96b9-41ac-0faf-e063-6294a90a8ab5 | 2024-01-26 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Allergy Relief | ALLERGY RELIEF | Good Sense | bb709377-7bb3-4931-a2b6-2443aee07c12 | 2024-01-26 | Warnings | M012 |
| Acetaminophen | ACETAMINOPHEN | Aurohealth LLC | f076fd33-9eaf-49b9-b0ee-6a349567c5ff | 2024-01-24 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc. | b70beee4-407e-547c-e053-2a95a90af22a | 2024-01-24 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.