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 102 of 397 · 7,939 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9%salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e7b329-e4e5-6991-e063-6294a90ac8172026-02-03WarningsExact identifier
unii: 451W47IQ8X
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.204025ac-af00-48a0-be8e-7ccc7a36ad452026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.3fceecc1-22b4-43a5-a4e0-d7d5634bcf812026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.60d8a79c-82a4-4312-b7c8-519e2000bc8e2026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Foster and Thrive Cherry Cough DropsMENTHOLMcKesson49eefa70-cef9-d7ec-e063-6294a90ac3212026-02-03WarningsExact identifier
unii: L7T10EIP3A
Eucalyptol, menthol, methyl salicylate, thymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDemoulas Super Markets, Inc51748426-047a-4ecf-b0fe-205667c9ef082026-02-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Foster and Thrive Honey Lemon Cough DropsMENTHOLMcKesson49f13ee3-6bb3-e500-e063-6394a90a152d2026-02-03WarningsExact identifier
unii: L7T10EIP3A
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
TheraCare Muscle and Join Pain Relieving CreamMENTHOL, METHYL SALICYLATEVeridian Healthcare18f9829e-c5f9-4253-e063-6394a90a70c62026-02-03WarningsExact identifier
unii: L7T10EIP3A
Foster and Thrive SF Honey Lemon Cough DropsMENTHOLMcKesson49f41c30-f806-44ba-e063-6394a90a5a672026-02-03WarningsExact identifier
unii: L7T10EIP3A
Nighttime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corpb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532026-02-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
tussin dm nighttime maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Inc1f3fb451-84c9-432e-ac67-2694dd66c8152026-02-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
Robafen DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINMajor Pharmaceuticals7c9660b7-cb00-449b-b65f-aa42d8ce19422026-02-03WarningsExact identifier
unii: 9D2RTI9KYH
AcetaminophenACETAMINOPHENHikma Pharmaceuticals USA Inc.7243bf2c-2c44-4dff-8a9e-d788d31dca862026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENPAI Holdings, LLC dba PAI Pharmac29b97e9-8097-4d87-a420-ccf5aec8274a2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leaderebfcb699-3369-4697-9841-44015b1c98082026-02-02WarningsExact identifier
unii: 9D2RTI9KYH
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
unii: L7T10EIP3A
Cherry Sore Throat LozengesBENZOCAINE, MENTHOLMeijer Distribution Inc.2f6de590-7cad-25d7-e054-00144ff8d46c2026-02-02WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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