NDC 51316-577 - Ultra concentrated Daytime/ Nighttime Severe Softgel

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
51316-577
Manufacturer
CVS PHARMACY, INC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CVS 647T Ultraconcentratd Daytime & Nighttime severe cold & flu softgelsCVS PHARMACY, INC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED2026-03-26HUMAN OTC DRUG LABEL

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 299 of 415 · 8,293 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength-Cough and Chest Congestion DMMAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.d1830989-fe82-4f08-8618-78979fcef5682024-11-25WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
ASP Daytime PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b84f2392-0b24-4af0-80f7-c45454093f512024-11-25WarningsExact identifier
application number: M012
rxcui: 1086997
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
ASP Nighttime MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.d8756d1f-baf5-412d-a493-a1c051eae3022024-11-25WarningsExact identifier
application number: M012
rxcui: 1297288
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
COMBOGESIC IVACETAMINOPHEN AND IBUPROFEN INJECTIONHikma Pharmaceuticals USA Inc.be408a5a-48e4-43c0-9cb1-bbf830b54f5b2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC508a65ee-42fa-4c0b-b24d-9faac6b0eba72024-11-24WarningsExact identifier
application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLCcb68eef0-b027-4bf1-b78f-f31844a8c06c2024-11-22WarningsExact identifier
application number: M012
rxcui: 2634363
rxcui: 1086997
rxcui: 1297288
BenadrylDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.de2a64ce-c169-4162-b79e-d3809bea21472024-11-22WarningsExact identifier
application number: M012
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
unii: 15FIX9V2JP
12 Hour Nasal Decongestant Extra MoisturizingNASAL SPRAYWinCo Foods LLC13fbde45-958c-455f-b766-f6a34342ee952024-11-21WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a01abac3-c13e-40f2-ae98-34bd6c9b75042024-11-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
rxcui: 1297288
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
rxcui: 1297288
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
rxcui: 1297288
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
unii: 6DC9Q167V3
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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