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 |
|---|---|---|---|---|---|---|
| SanaTos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 1fc1408c-c540-39ab-e063-6394a90aa477 | 2024-08-15 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Rite Aid Corporation | 8e1f223a-a3a0-4837-9847-2a3939fcc595 | 2024-08-15 | Warnings | 04JA59TNSJ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8b132cf3-c138-59ae-e053-2995a90a98a2 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 489645ad-d7da-5f52-e054-00144ff8d46c | 2024-08-14 | Warnings | M012 |
| Regular Strength Pain Relief | ACETAMINOPHEN | Bryant Ranch Prepack | 3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad24 | 2024-08-14 | Warnings | 362O9ITL9D |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 6c949602-e0c8-40ce-8fb3-5147f406fa04 | 2024-08-14 | Warnings | M012 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Bryant Ranch Prepack | 485fd02f-bfea-41d0-90a1-f12fcfeb2a15 | 2024-08-14 | Warnings | 04JA59TNSJ |
| Quality Choice Effervescent Antacid and Pain Relief - Extra Strength | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | Chain Drug Marketing Association | 1f926637-a61c-8eb7-e063-6394a90a6502 | 2024-08-13 | Warnings | XF417D3PSL |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 3dbdf020-ca17-1197-e054-00144ff8d46c | 2024-08-13 | Warnings | M012 |
| Empathy | AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA | Deseret Biologicals, Inc. | a89067c1-ef12-49da-8fa6-e65ff664f497 | 2024-08-13 | Warnings | 059QF0KO0R |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 445e49a2-6ed0-434c-aaea-3ce14bc7df59 | 2024-08-12 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | d49b42ad-0ae0-48c9-adba-5fc2ced97764 | 2024-08-12 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| RYMED | DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | EDWARDS PHARMACEUTICALS, INC. | c1d6e914-74cc-4cdf-9587-7eaaa4a386e5 | 2024-08-12 | Warnings | M012 04JA59TNSJ |
| ENDOCET | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | f11f356e-967d-4099-9d87-5497790b397c | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 6ad80616-b38d-4569-b24a-aa86e39feb66 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| dual action pain reliever | ACETAMINOPHEN AND IBUPROFEN | Bionpharma Inc. | 1f470b1b-81a9-e59c-e063-6394a90a4055 | 2024-08-09 | Warnings | 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 30da1bea-2dbc-4086-a5cf-8ed471bb6593 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 9f2127d9-d60b-42d3-9b6c-798e63dd68d1 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | c12c26be-ba05-4d25-a2bf-f87623c6ae57 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| dual action pain reliever | ACETAMINOPHEN AND IBUPROFEN | Bionpharma Inc. | 1f2f8fcf-bf08-2a21-e063-6394a90a9e71 | 2024-08-08 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.