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 table
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 table
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 table
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.

Matched openFDA labels page 144 of 339 · 6,762 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreen Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	b48d93fe-bb60-493f-8d1a-b2dc864203c4	2025-12-01	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012 rxcui: 1043543 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 495W7451VQ
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 495W7451VQ
Walgreens Childrens	NIGHTTIME COUGH	WALGREENS CO.	a270cbe3-bf0a-44da-9359-00e218eba239	2025-12-01	Warnings	Exact identifier unii: 9D2RTI9KYH
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 495W7451VQ
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012 rxcui: 1043543 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 495W7451VQ
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Advil Dual Action with Acetaminophen, Travel BASIX	IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	030d9bca-a934-6ef9-e063-6394a90a8277	2025-12-01	Warnings	Exact identifier unii: 362O9ITL9D
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	WALGREEN COMPANY	2969ba8f-c477-222a-e063-6394a90af703	2025-12-01	Warnings	Exact identifier application number: M012
CareALL Non Aspirin Extra Strength	ACETAMINOPHEN	New World Imports, Inc	da05a1a1-35b4-4787-8c56-12e369f18ff0	2025-12-01	Warnings	Exact identifier unii: 362O9ITL9D
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	80a699b9-bf5c-4765-9e20-ccbc7e3ace7a	2025-12-01	Warnings	Exact identifier unii: 362O9ITL9D
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	66244cdb-2680-4fa8-890d-32aefd490038	2025-12-01	Warnings	Exact identifier unii: 362O9ITL9D
CareAll Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS	New World Imports, Inc	4cd2f751-e072-4f4e-b059-ed1dfcc60c6b	2025-12-01	Warnings	Exact identifier application number: M012
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	7913bd41-a606-4ca6-b69f-2717c2f54b07	2025-12-01	Warnings	Exact identifier unii: 04JA59TNSJ
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Epic Pharma, LLC	700a229f-dc2d-7086-e053-2991aa0aec91	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.