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 |
|---|---|---|---|---|---|---|
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | e88731b1-a6a9-407a-b7f8-b58d88aa9264 | 2025-05-10 | Warnings | 362O9ITL9D |
| arthritis pain relief | ACETAMINOPHEN | Publix Super Markets Inc | af407852-5476-421d-a80a-d726c24b6391 | 2025-05-09 | Warnings | 362O9ITL9D |
| arthritis pain reliever | ACETAMINOPHEN | Walgreen Company | 5028c116-d0e3-4e30-8fa8-caaf08d99ec7 | 2025-05-09 | Warnings | 362O9ITL9D |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Safeway, Inc. | c639a36d-c683-4a4d-90b7-eadec7464aa2 | 2025-05-08 | Warnings | M012 |
| BUTAL/APAP/CAFFEINE | BUTAL/APAP/CAFFEINE | Direct_Rx | 2abb9915-edb2-6218-e063-6394a90ad462 | 2025-05-08 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| SUKKHI Polyamino Sugar Condensate Massage Cream | SUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 34aaf4ef-26dc-f87e-e063-6394a90a9a59 | 2025-05-08 | Warnings | PDC6A3C0OX |
| Guaifenesin | GUAIFENESIN | Aurohealth LLC | 4ec1477e-6e33-4c40-a476-cf7f4f00192b | 2025-05-08 | Warnings | 495W7451VQ |
| Guaifenesin | GUAIFENESIN | Aurohealth LLC | 30c27274-a051-4884-b41e-12943d92b199 | 2025-05-08 | Warnings | 495W7451VQ |
| Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645 | 2025-05-07 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Asclemed USA, Inc. | 702eb7c0-db4c-4729-b69e-99f64c63c7bd | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | 9D2RTI9KYH |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | 3febf0e0-b587-495a-9608-3a2dfbc32791 | 2025-05-07 | Warnings | 9D2RTI9KYH |
| Good Neighbor Pharmacy Infants Pain and Fever | ACETAMINOPHEN | Amerisource Bergen | 2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2 | 2025-05-06 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 2b962d87-6ff5-4c0f-8504-e5b61c940612 | 2025-05-05 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| 8hr arthritis pain relief | ACETAMINOPHEN | Major Pharmaceuticals | 31b3aaa2-8af2-670a-e063-6394a90a8003 | 2025-05-03 | Warnings | 362O9ITL9D |
| Cough and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID | CVS | 2d13564a-e8d1-c357-e063-6394a90ad90e | 2025-05-02 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol | OXYMETAZOLINE HYDROCHLORIDE | Kenvue Brands LLC | 33fe0e49-3de5-8afd-e063-6294a90a0ad5 | 2025-05-02 | Warnings | M012 |
| Daytime and Nighttime High Blood Pressure Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy, Inc. | 2d13964a-8cc4-f3dc-e063-6394a90aa105 | 2025-05-02 | Warnings | M012 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 34157f6a-3031-4388-e063-6394a90a670f | 2025-05-01 | Warnings | 362O9ITL9D |
| Phenylephrine hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | fad93be4-32dd-44c1-a20f-2b0bb3b41929 | 2025-05-01 | Warnings, Adverse reactions | 04JA59TNSJ |
| DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML | AARNA USA INC. | 32c26835-f54e-d7e5-e063-6294a90ae1c0 | 2025-04-30 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.