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 100 of 341 · 6,807 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE	WALGREENS	54aff6a0-2778-472f-90ba-375d6bce6ee8	2026-01-16	Warnings	Exact identifier unii: 362O9ITL9D
EXTRA STRENGTH HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN, CAFFEINE	WALGREENS	097fbab7-3886-4e75-b037-f03adcf3859f	2026-01-16	Warnings	Exact identifier unii: 362O9ITL9D
Cough Relief	DEXTROMETHORPHAN HBR	WALGREEN COMPANY	a793acbc-107c-4638-a2d7-65f4e96cafda	2026-01-16	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Walgreens	ca53ec26-d167-1780-e053-2a95a90a5b88	2026-01-16	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 495W7451VQ
Maximum Strength Congestion and Headache	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	88da92d2-92c2-445a-9b70-58996e086014	2026-01-16	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
Pain Reliever	ACETAMINOPHEN	WALGREENS CO.	bdb09e15-8e17-4987-99d0-bab8856a2109	2026-01-16	Warnings	Exact identifier unii: 362O9ITL9D
Maximum Strength Cold and Flu	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	5f638bca-55c2-4ead-8c47-3f15713495da	2026-01-16	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ
COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	190175bb-c08a-4050-aacf-29a130cbe05c	2026-01-16	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ
Night Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	FSA Store Inc. (Caring Mills)	a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff	2026-01-16	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Relief-PE	ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE	HART Health	9475fb51-931b-4a89-be6b-62e715d0883e	2026-01-15	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
WALGREENS UPSET STOMACH and NAUSEA RELIEF	SODIUM CITRATE DIHYDRATE	WALGREENS CO.	2de7ff66-af75-4d9d-b493-29b37dadc5d8	2026-01-15	Warnings	Exact identifier unii: B22547B95K
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	L.N.K. International, Inc.	99147338-f459-4423-ae54-f96fffc1728d	2026-01-15	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D
Hemorrhoidal Cream	HEMORRHOIDAL CREAM	Walgreens	1ac2b2ae-c090-483b-ad2c-1374552add4a	2026-01-15	Warnings	Exact identifier unii: PDC6A3C0OX unii: 04JA59TNSJ
Walgreens	HEMORRHOIDAL PAIN RELIEF	Walgreens	b0b1ce47-9fa4-4505-8f38-39a0d500e9f6	2026-01-15	Warnings	Exact identifier unii: 04JA59TNSJ
Walgreens Adult Glycerin Laxative	GLYCERIN SUPPOSITORY	Walgreens	f19c6cca-e763-4c38-a546-855f027d20c5	2026-01-15	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Adult Glycerin Laxative	GLYCERIN SUPPOSITORY	Walgreens	1a00ff43-ba79-4339-a547-f9757872958b	2026-01-15	Warnings	Exact identifier unii: PDC6A3C0OX
Hemorrhoidal Cream	HEMORRHOIDAL CREAM	Walgreens	4276ddad-2363-462a-bb97-574f946ec3f0	2026-01-15	Warnings	Exact identifier unii: PDC6A3C0OX unii: 04JA59TNSJ
Walgreens	HEMORRHOIDAL COOLING GEL	Walgreens	1277d2e8-2a5e-23f5-e063-6294a90a69b0	2026-01-15	Warnings	Exact identifier unii: 04JA59TNSJ
Hemorrhoid and Fissure	GLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%	FlexiGo Inc	48697377-61c0-1b0a-e063-6294a90a3293	2026-01-15	Warnings	Exact identifier unii: PDC6A3C0OX
acetaminophen	ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	4870ff00-f727-814d-e063-6394a90a6c8e	2026-01-15	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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