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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | BETTER LIVING BRANDS LLC. | ac0e5dc0-96eb-47b2-e053-2995a90add0e | 2025-12-18 | Warnings | 362O9ITL9D |
| Acetaminophen Diphenhydramine HCl | ACETAMINOPHEN DIPHENHYDRAMINE HCL | BETTER LIVING BRANDS LLC. | ac0f8d5c-d200-1156-e053-2a95a90aece6 | 2025-12-18 | Warnings | 362O9ITL9D |
| QUALITY CHOICE Cough Drops Vanilla Honey | MENTHOL | Chain Drug Marketing Association, Inc. | 3d6a4bcc-1044-40f5-928a-378ececcb687 | 2025-12-18 | Warnings | M012 |
| Meijer Strawberry Cough Drops | MENTHOL | Meijer | 164de637-e644-711c-e063-6294a90a1c5f | 2025-12-18 | Warnings | M012 |
| Meijer Severe Menthol Throat Drops | MENTHOL | Meijer | 16603ca4-1ce5-2e7e-e063-6394a90ad6f1 | 2025-12-18 | Warnings | M012 |
| Lemon | GLYCERIN | TwinMed LLC | fc88eec0-c66c-5d6d-e053-6294a90a13d2 | 2025-12-18 | Warnings | PDC6A3C0OX |
| Hepatatox | TRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUM | BioActive Nutritional, Inc | a113a9f1-4792-41a5-8d1b-a6756f356e15 | 2025-12-18 | Warnings | 506T60A25R |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 60587987-c303-4617-ba96-c518ab2a0650 | 2025-12-18 | Warnings | M012 |
| Acetaminophen | ACETAMINOPHEN | Caplin Steriles Limited | b6f83919-8608-4648-9ac6-e13eadac8404 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Pain and Fever Childrens | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e55645ab-66f9-4160-8247-395bc5b02711 | 2025-12-18 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma, LLC | 392a846e-7325-462d-b19b-8afda44c5cb0 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Dolex Forte | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pharmadel LLC | 3c2d90fc-130d-476c-e063-6294a90a8c15 | 2025-12-17 | Warnings | 362O9ITL9D |
| Niaflu | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 399898f0-e40a-4f5d-e063-6294a90a667d | 2025-12-17 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| HZ-Chord | BAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE) | Energetix Corporation | 9685aec5-a65d-40fe-b5d7-2f13a69733bc | 2025-12-17 | Warnings | XF417D3PSL |
| Cherry cough drop | MENTHOL | The Kroget Co. | 4313a6ce-454d-4c4b-e054-00144ff88e88 | 2025-12-17 | Warnings | M012 |
| Menthol cough drop | MENTHOL | The Kroger Co. | 42b257e9-f45e-32c9-e054-00144ff8d46c | 2025-12-17 | Warnings | M012 |
| Honey Lemon cough drop | MENTHOL | The Kroger Co. | 4318f25a-05d9-2208-e054-00144ff88e88 | 2025-12-17 | Warnings | M012 |
| Honey Lemon cough drop | MENTHOL | The Kroger Co. | 4317f952-a228-0281-e054-00144ff88e88 | 2025-12-17 | Warnings | M012 |
| Honey Lemon Cough Drop | MENTHOL | The Kroger Co. | 4316df6e-3ae6-4ab5-e054-00144ff88e88 | 2025-12-17 | Warnings | M012 |
| SF Honey Lemon Cough Drops | MENTHOL | The Kroger Co. | 43281bd1-f8a7-02a4-e054-00144ff8d46c | 2025-12-17 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.