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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Geltabs | ACETAMINOPHEN, ASPRIN, CAFFEINE | Haleon US Holdings LLC | 11a8439b-0159-4351-b0f5-fe7fad6a33c0 | 2024-03-05 | Warnings | 362O9ITL9D |
| Tramadol Hydrochloride and Acetaminophen | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Medsource Pharmaceuticals | 12f113b3-d6b1-a7b0-e063-6294a90a999d | 2024-03-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Multi-Symptom Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 3c7ef3cf-f7f9-42bc-bf20-e36954b9671f | 2024-03-05 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| ACETAMINOPHEN ASPIRIN AND CAFFEINE | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | WALMART INC. | 12942e9e-1385-5914-e063-6294a90aceac | 2024-03-05 | Warnings | 362O9ITL9D |
| Dolex Children Pain and Fever | ACETAMINOPHEN | Pharmadel LLC | f9158463-aeb1-5de0-e053-6294a90a748b | 2024-03-04 | Warnings | 362O9ITL9D |
| PREPARATION H | COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a23ded81-78ba-c199-a8f0-aaf360b216ff | 2024-03-02 | Warnings | 04JA59TNSJ |
| QUALITY CHOICE NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | da06e994-6848-4c1e-9432-31de5e626ea4 | 2024-03-02 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| QUALITY CHOICE DayTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 417c4fa9-6458-40d0-b22a-2415194e250f | 2024-03-02 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Aurohealth LLC | 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2 | 2024-03-01 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| PREPARATION H | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 507c08ab-a98b-33fe-e2ac-eb9b9a810d5a | 2024-02-29 | Warnings | 04JA59TNSJ |
| Preparation H Rapid Relief | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 27db1d58-4609-4a80-af2f-9e36f10482e1 | 2024-02-29 | Warnings | 04JA59TNSJ |
| Preparation H Rapid Relief | GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 699310e8-1a93-40b4-a8f4-a765be4a0cb1 | 2024-02-29 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 916ff456-a27e-49dc-a312-274126a8c30c | 2024-02-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| APRODINE | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | A-S Medication Solutions | bbc268b8-fa66-4dc5-b935-f77ae39d28c8 | 2024-02-29 | Warnings | M012 YAN7R5L890 |
| XtraCare Vaporizing Chest Rub | CAMPHOR, MENTHOL | Rejoice International | c3e220d6-fff4-452f-99a9-bd701fc608a0 | 2024-02-28 | Warnings | M012 |
| SEDALMEX FORTE | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Belmora LLC | 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d | 2024-02-28 | Warnings | 362O9ITL9D |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 396903dc-ae2d-4bf4-b1fd-0017b84abef9 | 2024-02-28 | Warnings | 362O9ITL9D |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 44730cbd-5b98-49bd-b3b8-6fecb0ccd153 | 2024-02-28 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 2024-02-27 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 1c93c45d-1141-4599-83ba-6d3b38f9ffc4 | 2024-02-23 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.