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 |
|---|---|---|---|---|---|---|
| Pharbetol Regular strength | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 05a91d24-b498-4ba2-a275-68b871cf62d2 | 2025-06-05 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | a6e9b316-549d-4058-8c08-407e4ce5c255 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | Haleon US Holdings LLC | becb4025-b63e-f2ea-9d11-d51fdf4e5c13 | 2025-06-04 | Warnings | M012 9D2RTI9KYH |
| Diphenhydramine HCL STRAWBERRY FLAVOR | DIPHENHYDRAMINE HCL | Innovida Pharmaeutique Corporation | 7eb709a5-c587-4f1d-bc2d-576d07a3a3bf | 2025-06-04 | Warnings | M012 |
| Hemorrhoid Master | LIDOCAINE, PHENYLEPHRINE HCL | Clinical Resolution Laboratory, Inc. | 36caf20d-116a-f86a-e063-6294a90a7b62 | 2025-06-04 | Warnings | 04JA59TNSJ |
| Dolo-NeuroBion | ACETAMINOPHEN | BENARD INDUSTRIES INC | b8310770-84d1-4a6f-8e23-9974947f92f1 | 2025-06-04 | Warnings | 362O9ITL9D |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | Rite Aid Corporation | 69bda7d7-8660-4e8d-b8ac-892a3b1f2124 | 2025-06-03 | Warnings | 362O9ITL9D |
| 8HR Muscle Aches and Pain Relief | ACETAMINOPHEN | LEADER/ Cardinal Health 110, Inc. | 331f4bd1-1303-cc48-e063-6394a90a74d3 | 2025-06-03 | Warnings | 362O9ITL9D |
| Children Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | TARGET CORPORATION | 69d33f77-06e1-48fa-a516-892fdf11bb1c | 2025-06-03 | Warnings | M012 |
| oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fd058e2b-5445-e416-e053-6394a90a611b | 2025-06-03 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 36b1a7e0-c8b9-0890-e063-6394a90ab13a | 2025-06-03 | Warnings | M012 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Advanced Rx of Tennessee, LLC | 36988ba2-cefd-99f8-e063-6294a90aa41a | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Advanced Rx of Tennessee, LLC | 3698e0ff-6a1c-e1ad-e063-6294a90a163a | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 7ab27392-9c6e-4ec3-85e7-06b43fcab3b1 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Mucus Relief | GUAIFENESIN | Bryant Ranch Prepack | c648e711-e944-4574-83b3-ccce8732384e | 2025-06-02 | Warnings | 495W7451VQ |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | caa96b80-d8a7-4920-9d5c-717435e798de | 2025-06-02 | Warnings, Adverse reactions | 362O9ITL9D |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Bryant Ranch Prepack | 2eefa0ac-70f6-43ab-b59e-c4ecad853fe7 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Kids Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | fb74e8f9-d72f-4681-90bd-df48364405b5 | 2025-06-01 | Warnings | 362O9ITL9D |
| COLD, FLU and SORE THROAT RELIEF | ACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MG | BETTER LIVING BRANDS, LLC | 202d60a8-83da-5afc-e063-6394a90ad779 | 2025-05-31 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Promethazine DM | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | PAI Holdings, LLC dba PAI Pharma | 1d47280d-28c9-4701-8c5f-a6e6b524083b | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | 9D2RTI9KYH |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.