Home NDC 51316-004 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 228 of 330 · 6,590 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola Ag ea42e516-2ef8-41c9-ae4e-571f0147bc6b 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola Ag 8b2d5c0f-509e-447d-b071-d73c4785f120 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag 8ae0e21a-44a0-4a2c-9880-54eeeaea07ea 2024-12-05 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 6d82469b-d51c-4824-9830-6c1874ad4fe4 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola Ag e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag a535717d-ba55-45e9-9fc3-711b5d7dbf57 2024-12-05 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola Ag 4330ee8d-0b37-4a93-886b-5fc6e6598da7 2024-12-05 Warnings Exact identifier application number: M012 Pain Reliever Extra Strength ACETAMINOPHEN Marc Glassman, Inc. 43bf297f-2832-424f-a013-4bfa1d6c03e6 2024-12-04 Warnings Exact identifier unii: 362O9ITL9D Acetaminophen ACETAMINOPHEN Precision Dose, Inc. 5a68ab98-720c-479a-a60a-4e594add6c09 2024-12-04 Warnings Exact identifier unii: 362O9ITL9D COLD AND FLU DAYTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TARGET CORP 9de99931-31ef-79e2-e053-2a95a90a98ad 2024-12-04 Warnings Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ Migrafein FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028875c9-4129-ce2c-e063-6294a90a26cc 2024-12-03 Warnings Exact identifier unii: 362O9ITL9D Neo-Lubrina Fuerte ACETAMINOPHEN, CAFFEINE OPMX LLC 0288a327-fd4b-1991-e063-6294a90ace50 2024-12-03 Warnings Exact identifier unii: 362O9ITL9D CAFIZETAMOL FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028771d3-a514-f7a5-e063-6394a90ac4f3 2024-12-03 Warnings Exact identifier unii: 362O9ITL9D Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE TopCo Associates LLC 3ef6d155-b95b-4b30-87a8-8ed811b1520f 2024-12-03 Warnings Exact identifier application number: M012 Sinus plus Headache ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE TOPCARE a1b2b16d-c767-2945-e053-2995a90a4834 2024-12-03 Warnings Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D Buscapina ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE OPMX LLC 048c4b03-1cf4-b724-e063-6294a90a1cad 2024-12-03 Warnings Exact identifier unii: 362O9ITL9D Sinus Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TopCare fa9b2748-0474-4a39-a2b8-bb6f0678c1d1 2024-12-03 Warnings Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ Sinus Pressure plus Pain PE ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE TOPCO ASSOCIATES LLC a9640e09-369c-3c55-e053-2a95a90aebd5 2024-12-03 Warnings Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D Cold Max ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TOPCO ASSOCIATES LLC ec7e5e2e-23c7-32ae-e053-2995a90a1251 2024-12-03 Warnings Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D COLD AND FLU SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE TOPCARE cbb179c8-31fb-4a3a-9f23-4024350f8b7f 2024-12-03 Warnings Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D unii: 495W7451VQ
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.