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 |
|---|---|---|---|---|---|---|
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Hi-Tech Nutraceuticals, LLC | b119ba37-0ee3-851a-e053-2995a90a85b1 | 2026-03-31 | Warnings | 362O9ITL9D |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 44217a8c-7656-a0f6-e063-6294a90af2ad | 2026-03-31 | Warnings | M012 |
| Dr Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CalmCo LLC | 3f156679-7a91-aff1-e063-6394a90a18f6 | 2026-03-31 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | A-S Medication Solutions | c26da6e0-ab1c-46c2-acf5-0074958c03cd | 2026-03-31 | Warnings | M012 495W7451VQ |
| Biorphen | PHENYLEPHRINE HYDROCHLORIDE | Dr. Reddy's Laboratories Inc. | 2f715e4e-b269-b935-d2c9-003cb29770be | 2026-03-31 | Warnings, Adverse reactions | 04JA59TNSJ |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | ba174fcc-da1e-420c-bf9c-179ad65c2848 | 2026-03-31 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | 8e0c6f8d-559c-45de-9362-1b713fd78a7a | 2026-03-30 | Warnings | M012 |
| Redness Relief | GLYCERIN, NAPHAZOLINE HCL | Pharmadel LLC | 4c113bb9-814f-d92d-e063-6294a90a8302 | 2026-03-30 | Warnings | PDC6A3C0OX |
| Hemorrhoidal | LIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUM | Walgreens Co | 3d213ba8-3cbe-11c4-e063-6394a90ae016 | 2026-03-30 | Warnings | 04JA59TNSJ |
| Dr. Simi Daytime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG | Farmacias De Similares TX LLC | 4e448fd0-cb6b-b69b-e063-6394a90afde8 | 2026-03-30 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Moisture Oyster | GLYCERIN | Moisture Oyster Inc | 4e45317a-437f-4d88-e063-6294a90a98d0 | 2026-03-30 | Warnings | PDC6A3C0OX |
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| allergy | DIPHENHYDRAMINE HCL | HyVee Inc | 75b19163-db1c-42fc-8bbb-364be16b9b2f | 2026-03-30 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | a9f23c63-eeda-4de9-aec6-fe482f469e98 | 2026-03-27 | Warnings | M012 |
| Good Sense Pain and Fever | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 7dbd0a2d-8597-4010-bfe2-94a8d145ca57 | 2026-03-27 | Warnings | 362O9ITL9D |
| Aveeno Skin Relief Healing | GLYCERIN | Kenvue Brands LLC | 345fdde5-700b-7103-e063-6394a90a0e3e | 2026-03-27 | Warnings | PDC6A3C0OX |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CHAIN DRUG MARKETING ASSOCIATION INC | 7d1b3418-85a8-4ca0-bca7-261b2b58032a | 2026-03-26 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Childrens Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 68e214cd-2d09-42d0-a4e9-b1b81af6be3c | 2026-03-26 | Warnings | 362O9ITL9D |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | a00dc563-6611-46b8-ab5c-1b2c602f3c68 | 2026-03-26 | Warnings | 362O9ITL9D |
| MAXIMUM STRENGTH COLD, FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy, Inc. | bfc38500-5706-0d03-e053-2995a90a5c72 | 2026-03-26 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.