NDC 51316-004 - 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
- 51316-004
- Package NDCs from labels
- 51316-004-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-004-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-004 | 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 |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | e451cb8d-f856-479f-bee9-4cccab210b1e | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 9D2RTI9KYH |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | 7f3c6dd7-6bc8-450e-aded-997f9cf63a8f | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Guaifenesin Extended Release 600 mg | GUAIFENESIN | TIME CAP LABORATORIES, INC. | 10c42869-7df0-3046-e063-6394a90aa679 | 2024-02-07 | Warnings | 495W7451VQ |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | e1799765-c247-42b4-ad6a-8ba7d136abf2 | 2024-02-06 | Warnings | 362O9ITL9D |
| Panadol Cold and Flu NonDrowsy | ACETAMINOPHEN AND PHENYLEPRINE HCL | Haleon US Holdings LLC | f626ab17-01c9-4493-ba9e-0c8c11146384 | 2024-02-06 | Warnings | 04JA59TNSJ 362O9ITL9D |
| PANADOL Extra | ACETAMINOPHEN AND CAFFEINE | Haleon US Holdings LLC | e5c2d88a-d903-4ca0-b895-f27e791dfc4e | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | 9d384e88-5c11-4600-ac6c-a38371570138 | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | 95801755-db54-4ad7-bec1-52671914f6ca | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 01e7dddb-755c-4745-b701-edcdb6209064 | 2024-02-06 | Warnings, Adverse reactions | 362O9ITL9D |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | fe7cd1f2-9b00-4ded-99c2-8a152c71093c | 2024-02-06 | Warnings, Adverse reactions | 362O9ITL9D |
| Topcare Dual Action Back Pain | ACETAMINOPHEN, IBUPROFEN | Topco Associates LLC | e40ec21c-6c44-4219-a94f-8b93a4853aa5 | 2024-02-06 | Warnings | 362O9ITL9D |
| Lidocaine Hemorrhoid | LIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZEL | Walgreens Co | 10a47899-f4a0-66e8-e063-6394a90a11dd | 2024-02-05 | Warnings | 04JA59TNSJ |
| Butal/APAP/Caff | BUTAL/APAP/CAFF | Direct_Rx | f6dc9bbc-3331-b422-e053-6394a90af9a1 | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | FSA Store Inc. (Caring Mills) | 57ade7e9-1c68-456c-8853-5acdef7e8f0e | 2024-02-05 | Warnings | 9D2RTI9KYH 495W7451VQ |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Maximum Strength Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | WALGREEN CO. | 83483b91-77e5-42ca-a467-21312ef32d30 | 2024-02-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Wal-Mart Stores, Inc. | 48ecf1f4-0571-4d7e-b0cc-309c88b7f1bf | 2024-02-03 | Warnings | 9D2RTI9KYH 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.