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 |
|---|---|---|---|---|---|---|
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | CVS Pharmacy | 845fc11b-707d-2027-e053-2991aa0a1c8a | 2025-10-24 | Warnings | 04JA59TNSJ |
| Menthol Drops Dollar General Severe 45ct | MENTHOL | Dollar General Corporation | c831d3d9-b910-40e6-bfdf-defe6850614d | 2025-10-24 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 7d2f3292-bb73-41dc-9729-edb83670be1b | 2025-10-24 | Warnings | M012 |
| Glycerin | GLYCERIN | CVS Pharmacy | 3a59c4a9-5f86-406a-e054-00144ff8d46c | 2025-10-24 | Warnings | PDC6A3C0OX |
| Freegells Cough Drops Menthol 30ct | MENTHOL | R.L. ALBERT & SON, INC | b174e57c-4e4f-4842-b8f2-f1b067764a68 | 2025-10-24 | Warnings | M012 |
| Glycerin | GLYCERIN | Cardinal Health | 7e7e9366-af1e-e0ff-e053-2a91aa0a9487 | 2025-10-24 | Warnings | PDC6A3C0OX |
| Glycerin | GLYCERIN | Cardinal Health | c2b02afc-5a8a-2a25-e053-2a95a90ae45c | 2025-10-24 | Warnings | PDC6A3C0OX |
| Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | Amerisourcebergen Drug Corporation | 231a850a-bad6-9a30-e063-6394a90a0fdc | 2025-10-24 | Warnings | 04JA59TNSJ |
| Signature Care Hemorrhoidal Cream (with applicator) | PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM | BETTER LIVING BRANDS, LLC | b026a386-5e38-52ed-e053-2a95a90a6b0e | 2025-10-24 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC. | 41eec9e9-6e94-15d4-e063-6394a90a98a2 | 2025-10-24 | Warnings, Adverse reactions | 04JA59TNSJ |
| Guaifenesin and Pseudoephedrine HCL | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Dr. Reddys Laboratories Limited | 845a2dcc-9069-3141-ae13-f2063f36d130 | 2025-10-24 | Warnings | 495W7451VQ |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 17640528-c1f7-4881-ba86-bb3f488a952c | 2025-10-24 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Chloraseptic Total Sore Throat and Cough, Sugar Free | MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Prestige Brands Holdings, Inc. | 34e4234c-ed61-4795-99fe-d281cdb0af88 | 2025-10-23 | Warnings | 9D2RTI9KYH |
| Chloraseptic Total Sore Throat and Cough | MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Prestige Brands Holdings, Inc. | 6b1a50d0-be54-4fcb-b5e2-b47abf3555c0 | 2025-10-23 | Warnings | 9D2RTI9KYH |
| GOODYS Extra Strength Headache Mixed Fruit Blast | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 6cb758bf-5a50-46bb-96e7-65b810b12de0 | 2025-10-23 | Warnings | 362O9ITL9D |
| Vapor Stick | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 33e259d6-b065-a677-e063-6394a90ab314 | 2025-10-23 | Warnings | M012 |
| Lemon Glycerine Swabsticks | GLYCERINE | PHOENIX HEALTHCARE SOLUTIONS, LLC | 436919f7-14cd-4318-9388-b3e1cbec176b | 2025-10-23 | Warnings | PDC6A3C0OX |
| Advanced Eye Relief Dry Eye Rejuvenation | GLYCERIN PROPYLENE GLYCOL | Bausch & Lomb Incorporated | 027969ee-64e4-4b08-bab7-c4cc8ed22f5f | 2025-10-23 | Warnings | 6DC9Q167V3 PDC6A3C0OX |
| Winco Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 04ca3ef1-fc6b-4683-b236-a75afc031fb5 | 2025-10-23 | Warnings | 04JA59TNSJ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 36bf5e37-9202-4288-8354-9d123fb692d3 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.