Home NDC 51316-063 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 209 of 336 · 6,712 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Cough Drops Honey Vanilla Flavor MENTHOL 7-ELEVEN 2f3c43dd-175f-722e-e063-6294a90acff9 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN 7-ELEVEN 2f3c3c65-4178-6304-e063-6294a90a51fa 2025-02-28 Warnings Exact identifier application number: M012 Curist Mucus Relief GUAIFENESIN Little Pharma, Inc. d8892a82-25a7-552d-e053-2a95a90a72fd 2025-02-27 Warnings Exact identifier unii: 495W7451VQ AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier unii: 362O9ITL9D AeroWash Eyewash EYEWASH SOLUTION Aero Healthcare US LLC a477de08-4301-0ee5-e053-2995a90af79d 2025-02-26 Warnings Exact identifier unii: 059QF0KO0R Blink Nourish Dry Eye GLYCERIN Bausch & Lomb Incorporated cf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a4 2025-02-25 Warnings Exact identifier unii: PDC6A3C0OX Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 2025-02-25 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efc46c9-a421-1998-e063-6394a90aeb64 2025-02-25 Warnings Exact identifier application number: M012 Redicare Cough Drops Cherry Flavored CHERRY FLAVORED MENTHOL COUGH DROPS Redicare LLC 2efeaafa-ee96-37ee-e063-6394a90a9a4b 2025-02-25 Warnings Exact identifier application number: M012 Mucus Relief Max GUAIFENESIN Discount Drug Mart, Inc 2df7e36d-8eb6-827b-e063-6294a90acb1d 2025-02-24 Warnings Exact identifier unii: 495W7451VQ Acetaminophen ACETAMINOPHEN TABLET EXTENDED RELEASE Asclemed USA, Inc. 4ef6bc2b-03cf-474f-bb9e-dbb5792ec197 2025-02-24 Warnings Exact identifier unii: 362O9ITL9D Mucus Relief GUAIFENESIN Discount Drug Mart, Inc 2d5940b8-fdae-edf2-e063-6294a90a68fc 2025-02-24 Warnings Exact identifier unii: 495W7451VQ Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier unii: 362O9ITL9D HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN Direct Rx db73b8ed-9747-6a49-e053-2a95a90a93a1 2025-02-21 Adverse reactions Exact identifier unii: 362O9ITL9D HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN DirectRx dd934235-3b2a-51ca-e053-2995a90a0016 2025-02-21 Warnings, Adverse reactions Exact identifier unii: 362O9ITL9D Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier unii: 362O9ITL9D Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier unii: 362O9ITL9D Childrens Allergy DIPHENHYDRAMINE HCL Genexa Inc. e880b8d7-61c3-41cc-e053-2995a90aaaeb 2025-02-20 Warnings Exact identifier application number: M012 Gencare-Nasal Decongestant PE PHENYLEPHRINE HYDROCHLORIDE Pioneer Life Sciences, LLC 596ec923-56a0-4b6e-a69c-8d740feb75a2 2025-02-20 Warnings Exact identifier application number: M012 unii: 04JA59TNSJ FEELSHION Glycolic Acid Exfoliating Face Pads PROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACID Beijing JUNGE Technology Co., Ltd. 2e79678c-1ce4-25cf-e063-6394a90a133c 2025-02-19 Warnings Exact identifier unii: 6DC9Q167V3
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.