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 |
|---|---|---|---|---|---|---|
| equate infants pain and fever | ACETAMINOPHEN | WALMART INC. | 34b2512e-743b-45db-92cb-ea05e2f47b3d | 2024-10-31 | Warnings | 362O9ITL9D |
| XS H2O Liquescence | VALERIANA OFFICINALIS, CITRICUM ACIDUM, POTASSIUM BITARTRATE, ALLIUM SATIVUM, ARTERIA SUIS, CEREBRUM SUIS, KIDNEY (SUIS) RAUWOLFIA SERPENTINA, ADRENOCORTICOTROPHIN | Nutritional Specialties, Inc. | 16a266cd-79cc-4f1d-839c-45183107e82c | 2024-10-31 | Warnings | XF417D3PSL |
| Addiclenz | BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | 8a3b75ca-8fec-4318-8a55-8bde0b82637d | 2024-10-31 | Warnings | OJ245FE5EU |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe | 2024-10-31 | Warnings | M012 |
| foster and thrive infants pain and fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 45770ad6-9bf7-41bd-a724-e5260cd31fa1 | 2024-10-31 | Warnings | 362O9ITL9D |
| CareOne Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | American Sales Company | 819d5c82-0240-4013-9904-c335bd65d03e | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| RiteAid Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN | RITE AID CORPORATION | 54fc0893-9702-4849-a702-3e84dc9ead03 | 2024-10-30 | Warnings | 362O9ITL9D |
| Signature Care Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway | 9a0ad5d5-8fd9-468d-be2c-87c14d08b934 | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Promethazine Hydrochloride and Phenylephrine Hydrochloride | PROMETHAZINE AND PHENYLEPHRINE | Amneal Pharmaceuticals LLC | cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 | 2024-10-30 | Warnings, Adverse reactions | 04JA59TNSJ |
| Good Sense Severe NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| dg health cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Dolgencorp, LLC | 81f3ac36-9bae-4f42-92a0-8a2e4bbd0984 | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Midol Complete | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET | Lil' Drug Store Products, Inc. | d20425a4-f074-4154-e053-2995a90ae9fd | 2024-10-30 | Warnings | 362O9ITL9D |
| up and up infants acetaminophen | ACETAMINOPHEN | Target Corporation | 31104956-04d7-41b5-82be-219ded5c02a9 | 2024-10-30 | Warnings | 362O9ITL9D |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Rite Aid Corporation | 9a71e8eb-4195-4694-bf3e-44f691ff2cef | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | H E B | fe4a95d2-6fb3-43fe-baec-6f22d1965323 | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger Company | 2c9ef0d7-3d5b-494a-8f06-9dd42110d78a | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Amneal Pharmaceuticals LLC | 6081c216-0bed-40f0-8732-f999647003d5 | 2024-10-30 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Severe Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Spleenex VH | ARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUS | Energique, Inc. | 54e2c88e-2483-4c38-86e5-19e218e713ae | 2024-10-30 | Warnings | XF417D3PSL |
| equaline nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 4e0c6ad6-81ef-4b0e-b2eb-44256faf7358 | 2024-10-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.