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
LabelManufacturerEffective dateType
CVS 44-004063CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.2025-10-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-063-45Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime177 mL in 1 BOTTLE, PLASTICSOLUTION177 mL650 mg in 20mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-063SEVERE CONGESTION, COUGH, COLD AND FLU RELIEF MAXIMUM STRENGTH, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]4Unmatched20241017_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 269 of 330 · 6,590 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
unii: 495W7451VQ
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
unii: 495W7451VQ
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact identifier
application number: M012
Herbal Flavor Menthol Cough DropsHERBAL FLAVOR MENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb848b6-3dec-5b5f-e063-6394a90aea142024-08-02WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb8927b-22c5-2ca3-e063-6294a90aa5632024-08-02WarningsExact identifier
application number: M012
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
unii: 362O9ITL9D
No Drip Severe Anefrin Nasal0.05% OXYMETAZOLINE HCLWalgreens Companyc126e969-56f3-47b4-a011-02ff150eccb82024-08-02WarningsExact identifier
application number: M012
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRH E B20df2ffe-5281-4cd6-adb3-3a3d28788ef62024-08-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRH E Bbcc41783-9213-4a8e-b7db-75b4da08551d2024-08-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRH E B187097bf-37c8-4184-a2fd-1eff9147d3702024-08-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
unii: 362O9ITL9D
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation90e0426b-654f-4bcd-8b1d-cf56d1fc0c682024-07-27WarningsExact identifier
application number: M012
Guaifenesin 600 mgGUAIFENESINDr. Reddy's Laboratories Inc.99307c61-5df3-0a83-1e21-ddb03bc905b42024-07-26WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINAmerican Health Packaging0129f47d-abc2-414c-b4e1-1064c5d6a6232024-07-25WarningsExact identifier
unii: 495W7451VQ
8 Hour Pain ReliefACETAMINOPHENAMERISOURCE BERGEN9ab903aa-7170-460b-9527-e3df223f5f552024-07-24WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.1e01f923-38c1-9b59-e063-6394a90a22f12024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
nasal decongestantOXYMETAZOLINE HCLA-S Medication Solutions0e81a937-59e5-4869-8ffb-c758fb37230d2024-07-23WarningsExact identifier
application number: M012
ACETAMINOPHENACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP92c22593-daf9-20a8-e053-2a95a90a365d2024-07-23WarningsExact identifier
unii: 362O9ITL9D
WesTussin DMDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWestminster Pharmaceuticals, LLC68a0cd44-3fdd-430e-af1a-498d4415ab782024-07-23WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGLil' Drug Store Products, Inc.edc244d6-eb0b-d3c9-e053-2a95a90a26222024-07-22WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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