FDA.reportPublic FDA data

NDC 55319-036 - Family Dollar Daytime and Nighttime Combo Pack Cold and Flu

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
55319-036
Package NDCs from labels
55319-036-08
Manufacturer
FAMILY DOLLAR SERVICES INC
Effective date
2023-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FD DayTime Cold and Flu Relief - FAMILY DOLLAR SERVICES INCFAMILY DOLLAR SERVICES INC2023-09-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-036-08Family Dollar Daytime and Nighttime Combo PackCold and Flu236 mL in 1 BOTTLELIQUID236 mL5 mg in 15mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-036FAMILY DOLLAR DAYTIME AND NIGHTTIME COMBO PACK COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [FAMILY DOLLAR SERVICES INC]1Unmatched20230910_8baef60a-6aee-4e13-b2c8-e52aa6dffba5.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 65 of 399 · 7,980 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
rxcui: 1113705
rxcui: 1043400
rxcui: 2637726
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCamber Pharmaceuticals, Inc.1c8fef8f-2ff5-4bea-bccb-90c2c8544c212026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAtlantic Biologicals Corp.5022379d-05ef-63f2-e063-6294a90a21892026-04-23Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.48912649-9fa1-a11f-e063-6294a90a8a722026-04-23WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a70867e-481d-4f01-9da3-d85663a1672e2026-04-23WarningsExact identifier
unii: 362O9ITL9D
GUAIFENESIN AND DEXTROMETHORPHAN HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRTOPCO ASSOCIATES LLC3a9737c0-e413-dfd1-e063-6294a90aaebd2026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCardinal Health 107, LLCee50c5ee-1a61-4efc-aca9-42d897d6a3b82026-04-22WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack69ce724d-6440-4def-aea9-26ad284ac35c2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack639aba0b-1ef6-415f-9732-ebf52bcc1b862026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INCf2eb5494-2672-444f-afa3-d1ef8ed1eaa12026-04-22WarningsExact identifier
unii: 9D2RTI9KYH
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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