NDC 51316-063 - 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
- 51316-063
- Package NDCs from labels
- 51316-063-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-063-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 650 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-063 | 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 |
|---|---|---|---|---|---|---|
| Freegells Cough Drops Menthol Strawberry | MENTHOL | Riclan S.A. | da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 | 2023-10-26 | Warnings | M012 |
| DG Health Cough Drops Assorted Flavors | MENTHOL | Dollar General Corporation | c731d255-40f2-3cb3-e053-2a95a90a8877 | 2023-10-26 | Warnings | M012 |
| Family Wellness | PHENYLEPHRINE HCL, PETROLATUM, MINERAL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bfa195d7-d87f-43b5-bbf1-7ec3a451de05 | 2023-10-25 | Warnings | 04JA59TNSJ |
| TheraPlus Plus | PHENYLEPHRINE HCI | Zhejiang Jingwei Pharmaceutical Co., Ltd. | edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d | 2023-10-25 | Warnings | 04JA59TNSJ |
| Hemorrhoidal Cream | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM | Cardinal Health 110, LLC. dba Leader | 85a51d5c-679e-1959-e053-2a91aa0a76d5 | 2023-10-25 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| Family Wellness | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fde9cd90-d63c-4058-b46e-511fecea36ec | 2023-10-24 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| ALKA SELTZER PLUS Cold Day and Night Effervescent | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Sincronia Logistica, S.A. de C.V. | c478df69-823a-4112-8f44-323249a9f38f | 2023-10-23 | Warnings | M012 9D2RTI9KYH |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 169006cb-7dc2-4113-a289-0b1f14e784b7 | 2023-10-23 | Warnings | M012 |
| MUCINEX | GUAIFENESIN | A-S Medication Solutions | 08ea92cc-4a0f-44c9-9edf-71f67e014431 | 2023-10-23 | Warnings | 495W7451VQ |
| ROBAFEN DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | A-S Medication Solutions | d5965f49-2b89-425c-9909-c75c87f930fc | 2023-10-22 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Night-Time Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | HealthLife of USA | 2ffd62a6-703f-4cb0-bb13-49719c004d00 | 2023-10-21 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | WALGREENS | f3c69974-7f51-2227-e053-2995a90a5570 | 2023-10-21 | Warnings | 362O9ITL9D |
| Day-Time Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN | HealthLife of USA | c5f6cf22-2aaa-40e1-b7b3-448e55898d62 | 2023-10-21 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| PENTREXCILINA | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Healthlife of USA | ae9ada14-0ec8-4c01-a874-237f2108936a | 2023-10-21 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Menstrual Complete | MENSTRUAL COMPLETE | Healthlife of USA | c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33 | 2023-10-21 | Warnings | 362O9ITL9D |
| Guaifenesin | GUAIFENESIN | APNAR PHARMA LP | e5004c10-3877-c199-e053-2a95a90aa8ac | 2023-10-21 | Boxed warning, Warnings | M012 495W7451VQ |
| Extra Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | e65dbd01-2d5e-4067-ad98-98d879cfb5ee | 2023-10-19 | Warnings | 362O9ITL9D |
| Regular Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | f06fe167-8a16-14d9-e053-2a95a90a1a0f | 2023-10-17 | Warnings | 362O9ITL9D |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | BLESSINGS INTERNATIONAL | ee8ba190-2c42-7ca2-e053-2a95a90a01a0 | 2023-10-17 | Warnings | 362O9ITL9D |
| Acetaminophen Extended-Release Tablets, 650 mg | ACETAMINOPHEN | MARKSANS PHARMA LIMITED | d973a910-5fe0-4a85-884d-2c3987836691 | 2023-10-17 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.