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 |
|---|---|---|---|---|---|---|
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 3fb49f64-2d77-44db-8186-5904837eedbe | 2026-02-17 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Genus Lifesciences Inc. | 26242cd7-1dbe-4ca4-88ca-5b98a6566ff9 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b | 2026-02-17 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | e8a48a00-3533-4c4d-94e1-8a6c6b35a792 | 2026-02-17 | Warnings | M012 |
| MUCUS AND CHEST CONGESTION | GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f341aa99-5339-4087-a98a-469231dfc6d0 | 2026-02-17 | Warnings | 495W7451VQ |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | 1f3efcdd-4976-4aef-a7c6-a5f88d13cb78 | 2026-02-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1 | 2026-02-17 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | HyVee Inc | d5bbb5e1-ff09-4563-b2c6-149ab30e06ad | 2026-02-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Chain Drug Marketing Association, Inc. | 3c8f34ad-589a-4872-939c-44ad5e0e47fe | 2026-02-17 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| CHILDRENS Acetaminophen | CHILDRENS ACETAMINOPHEN | Kesin Pharma Corporation | 4af5b025-1fd7-e825-e063-6294a90aa005 | 2026-02-16 | Warnings | 362O9ITL9D |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Valu Merchandisers Company | b6144732-99da-4be2-88e0-75f31b323d38 | 2026-02-16 | Warnings, Adverse reactions | M012 |
| topcare day time cold and flu relief multi symptom relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates LLC | 6d08ca2d-6ae4-443f-9920-34b7fb46f2b4 | 2026-02-16 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Infants TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 4a121a53-dbae-05c7-e063-6294a90aed89 | 2026-02-13 | Warnings | 362O9ITL9D |
| Revasol Acetaminophen Suspension | ACETAMINOPHEN | Rnv LLC | 4ab6bb54-7c28-0c6b-e063-6394a90ac4a6 | 2026-02-13 | Warnings | M012 362O9ITL9D |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Topco Associates LLC | 62eed0e8-ba5f-45c2-a543-68b50bcf4b0c | 2026-02-13 | Warnings, Adverse reactions | M012 |
| MAX relief junior Grape | CHILDRENS ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 562d7901-44d6-4d9b-be8b-a8d468a22c43 | 2026-02-13 | Warnings | 362O9ITL9D |
| Revasol Acetaminophen Suspension Dye Free | ACETAMINOPHEN | Rnv LLC | 4abc07b3-6a27-260f-e063-6394a90a28d6 | 2026-02-13 | Warnings | M012 362O9ITL9D |
| robafen dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Major Pharmaceuticals | 5e19220d-9cf3-4732-b9aa-c09db5d69ce6 | 2026-02-13 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| acetaminophen | ACETAMINOPHEN | Major Pharmaceuticals | 020fa486-31f0-4e0c-84d3-5b3aaded1eeb | 2026-02-13 | Warnings | 362O9ITL9D |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 686b9456-f16d-4b99-ae58-f607448bed8b | 2026-02-13 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.