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 |
|---|---|---|---|---|---|---|
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 3e50b3f6-1e1a-41b9-e063-6394a90abe36 | 2025-11-03 | Warnings | 362O9ITL9D |
| VANACOF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | 2ed699f2-d004-4fa9-8042-6c85a9ff69b6 | 2025-11-03 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 495W7451VQ |
| Systane Complete PF | PROPYLENE GLYCOL EMULSION | Alcon Laboratories, Inc. | 798ffdde-1dba-4a3f-a0b6-937f9e958cca | 2025-11-03 | Warnings | 6DC9Q167V3 |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 447de441-7d28-4415-81c5-4fc05622dd05 | 2025-11-03 | Warnings | 362O9ITL9D |
| Geri Dryl | DIPHENHYDRAMINE HCL | VERITYRX, LLC | 42a05f69-0599-5571-e063-6394a90a37d3 | 2025-11-02 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | VERITYRX, LLC | 42a0e577-a1b6-2c16-e063-6294a90af8e3 | 2025-11-02 | Warnings | M012 |
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | VERITYRX. LLC | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 2025-11-02 | Warnings | 362O9ITL9D |
| M-PAP | ACETAMINOPHEN | VERITYRX, LLC | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 2025-11-02 | Warnings | 362O9ITL9D |
| good sense cough dm | DEXTROMETHORPHAN POLISTIREX | L. Perrigo Company | 1b11b25b-2716-45f9-830f-ddf622366e60 | 2025-11-02 | Warnings | 9D2RTI9KYH |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | H E B | f8f225cd-a0f2-4991-828f-cc7549778235 | 2025-11-01 | Warnings | 9D2RTI9KYH |
| Topcare Cough DM | DEXTROMETHORPHAN POLISTIREX | Topco Associates LLC | d1740816-425d-4327-9cff-6ca5ce430d0c | 2025-10-31 | Warnings | 9D2RTI9KYH |
| phenylephrine hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f454c289-5a31-4bd3-86a2-1281bf1ab14b | 2025-10-31 | Warnings, Adverse reactions | 04JA59TNSJ |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | c296efd0-5030-4a26-a9b0-e66423d995dc | 2025-10-31 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| PhysiciansCare Non Aspirin Extra Strength | ACETAMINOPHEN | Acme United Corporation | c7006775-bd5b-412f-963d-ce5a158216c5 | 2025-10-31 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Max Maximum Strength Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates, LLC | f7ebe482-cb22-4517-8463-3432cf60071d | 2025-10-31 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Nighttime Cold and Flu Max Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 787bff76-0ee2-4e7e-b908-876e4a3e3bfc | 2025-10-31 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | Walgreens | f7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba | 2025-10-31 | Warnings | 362O9ITL9D |
| Honey Lemon Cough Drops | MENTHOL | Trader Joe's Company | 647dadae-f37a-8399-e053-2991aa0aedb3 | 2025-10-31 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.