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 |
|---|---|---|---|---|---|---|
| Pain Relief | ACETAMINOPHEN | AMERISOURCE BERGEN | 2b923a97-836c-4dac-a8c0-3047a35fb62e | 2024-02-23 | Warnings | 362O9ITL9D |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 3dc293c9-736b-4bd8-b993-ff83b9909bcd | 2024-02-23 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Childrens Dibromm Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health (Leader) 70000 | 10cc7d67-30c4-4451-bf74-78abae3c8e25 | 2024-02-23 | Warnings | M012 04JA59TNSJ |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c600fe14-40b6-2b5a-e053-2a95a90aff98 | 2024-02-22 | Warnings, Adverse reactions | 04JA59TNSJ |
| PHENYLEPHRINE HCI | PHENYLEPHRINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 7602fb73-3ce3-5978-e053-2991aa0abea3 | 2024-02-22 | Warnings, Adverse reactions | 04JA59TNSJ |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | BJWC (Berkley & Jensen / BJ's) | b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 | 2024-02-22 | Warnings | 362O9ITL9D |
| GI Drainage | CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS | Deseret Biologicals, Inc. | ff81e3ca-2f88-4daf-a734-083107269d3a | 2024-02-21 | Warnings | 059QF0KO0R |
| Good Sense Mucus ER | GUAIFENESIN | L. Perrigo Company | 49de9c3b-9840-4fc2-988f-4361de6aa3c1 | 2024-02-21 | Warnings | 495W7451VQ |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | LGM PHARMA SOLUTIONS, LLC | f6548126-faa1-4f53-8e0b-bc1b743de04d | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nasal Spray, 24-7 for Life | OXYMETAZOLINE HYDROCHLORIDE 0.05% | Lil' Drug Store Products, Inc. | 11d27c75-fd95-f9da-e063-6394a90ac6b0 | 2024-02-20 | Warnings | M012 |
| Basic Care Dual Action | ACETAMINOPHEN, IBUPROFEN | Amazon.com Services LLC | 7e27f5cb-8728-400f-82c5-0984276aa5dd | 2024-02-20 | Warnings | 362O9ITL9D |
| Nighttime Cold and Cough childrens | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 11652e8a-2242-4449-8a41-a8e75509025e | 2024-02-20 | Warnings | M012 04JA59TNSJ |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 31a41976-7f65-42d7-acf5-de9c2c5ca58e | 2024-02-20 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen and Caffeine | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | KVK-Tech, Inc. | 7f9c4668-4f4a-453b-b2fa-a6fed903ddfa | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | A-S Medication Solutions | f822c103-b678-4e76-8174-33b94421dd1e | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 48cc1378-ffab-4645-95bb-a05d78066575 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | 115d0b4f-6f0f-79a9-e063-6394a90ab18a | 2024-02-14 | Warnings | 362O9ITL9D |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.