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 | CVS Pharmacy, Inc | c4473ee6-4e01-1ec2-e053-2995a90ac513 | 2024-12-02 | Warnings | 362O9ITL9D |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Strategic Sourcing Services LLC | 27f85134-cd38-b33c-e063-6394a90a05a8 | 2024-11-28 | Warnings | 495W7451VQ |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 22f63d62-c941-5b8f-e063-6394a90aeecd | 2024-11-28 | Warnings | 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a7b6318-b7d6-31b1-e053-2991aa0abf25 | 2024-11-28 | Warnings | 362O9ITL9D |
| Extra Strength Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | INGLES MARKETS, INC. | 27fd288e-c07a-617f-e063-6394a90a17a4 | 2024-11-28 | Warnings | 362O9ITL9D |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Geri-Care Pharmaceutical Corp | ac8a14ac-7023-1e23-e053-2995a90aea3a | 2024-11-28 | Warnings | M012 |
| Childrens Benadryl DYE-FREE ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 10d478ff-ddc6-45da-87ff-cfe1b2b07a8e | 2024-11-27 | Warnings | M012 |
| EXCEDRIN MIGRAINE | ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE | Jones Healthcare Group - Packaging Services, Inc | c4168e4d-3dfc-4e51-a32e-14704cb59c66 | 2024-11-27 | Warnings | 362O9ITL9D |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | 9cd10af6-a2fa-44f8-8df3-a6d2a95a5293 | 2024-11-27 | Warnings | M012 |
| Severe Sinus Congestion Allergy and Cough Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 36a4ec1f-50c3-4d61-ada9-987ccad3563c | 2024-11-26 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| First Aid Only Extra-Strength Non-Aspirin | ACETAMINOPHEN | Acme United Corporation | 6891d57a-10a6-53de-e053-2a91aa0ac7c2 | 2024-11-26 | Warnings | 362O9ITL9D |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| BRONCOCHEM COLD AND FLU CAPLETS | ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6 | 2024-11-26 | Warnings | 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Daytime Nighttime Childrens Multi-symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | 177e3247-402d-98e4-e063-6294a90ae068 | 2024-11-26 | Warnings | M012 1043543 |
| Alka-Seltzer Plus Cold and Flu, CVP | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET | Lil' Drug Store Products, Inc. | e7a27773-69d6-9e07-e053-2a95a90af8ea | 2024-11-25 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 06eabf4b-f8c0-439a-acf1-aa6e3075c717 | 2024-11-25 | Warnings | 362O9ITL9D |
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | a352f588-4a70-42b2-8f9c-a73a0629517d | 2024-11-25 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.