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 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
51316-004-45	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 table
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.

Matched openFDA labels page 301 of 330 · 6,590 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	0239ada0-644d-4ef4-a3b8-df70246a3bc2	2023-12-21	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	a698502d-c1c5-41ca-8142-74338b834c8b	2023-12-21	Warnings	Exact identifier application number: M012
Walgreens Multi-Symptom Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Walgreen Co.	a03789ce-66bd-7b12-e053-2995a90af85a	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Eye Drops Maximum Redness Relief 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	949d4a4d-b0f8-81f8-e053-2995a90a818d	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops High Performance 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94ee8310-1c19-dfd4-e053-2a95a90a8356	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Walgreens Redness Relief Eye Drops 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	94a0d08a-a6db-1088-e053-2995a90ab4fd	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94f6e1cd-073c-61ca-e053-2a95a90ae725	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Father Johns Cough Medicine Plus	NASAL DECONGESTANT	Oakhurst Company	8b8aab0f-251b-6bd8-e053-2995a90ad748	2023-12-18	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ
Father Johns Medicine	DEXTROMETHORPHAN HBR	Oakhurst Company	8b8a249d-55af-cc98-e053-2995a90a431d	2023-12-18	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
HEB Extra Strength Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	9e502bd0-8042-8674-e053-2995a90a3d15	2023-12-18	Warnings	Exact identifier unii: XF417D3PSL
Tension Headache Pain Relieving Aid	ACETAMINOPHEN,CAFFEINE	WAL-MART STORES INC	00fadd26-a6eb-dc5e-e063-6394a90a3cca	2023-12-15	Warnings	Exact identifier unii: 362O9ITL9D
Daytime Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79d92d2-d73c-d44f-e053-2995a90a03d9	2023-12-15	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ
Cleareyes Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Lil' Drug Store Products, Inc.	39e4ab2b-ae12-4339-b219-109cf0f7f06a	2023-12-15	Warnings	Exact identifier unii: PDC6A3C0OX
Pain Reliever	ACETAMINOPHEN TABLET, EXTRA STRENGTH	Lil' Drug Store Products, Inc.	f0fdab5a-9d07-57aa-e053-2a95a90adc7f	2023-12-15	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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