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 80 of 397 · 7,939 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackdb14e63a-8e3e-4524-b45a-cb09f705f73a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5b559c3-4beb-4ba3-a10b-7a1ad1878a1e2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1170f2f0-f087-4b68-afb5-7c049cb9a6192026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)778dc0fb-30c3-4fbf-856a-7bca28181b392026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Severe Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db0470b-1bf0-9137-e063-6394a90a1d542026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db066d4-ddbe-ddce-e063-6394a90ac5f82026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
unii: 362O9ITL9D
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola Ag27487e5c-044c-41eb-865f-2f34351afd522026-03-23WarningsExact identifier
unii: L7T10EIP3A
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacke73b17c4-9f24-4b32-8920-61c58c40a7142026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc534f784-0e21-4891-8f7e-2dc327b267f12026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola Agd63b4d24-e926-418c-bb17-420aeaad5a622026-03-23WarningsExact identifier
unii: L7T10EIP3A
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6e7dfee1-3de9-46c8-9b58-83fcf8ee72e02026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESINHyvee Inc44eafc83-8e7b-89b8-e063-6394a90ab0bc2026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack879db1b5-6365-4151-9879-80d8a2a3cd8a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola USA Inc.5d7889b1-3866-49b0-97e1-1e883a52d3cb2026-03-23WarningsExact identifier
unii: L7T10EIP3A
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola USA Inc.1487652c-dbc1-40f4-9d59-891ec74cc3632026-03-23WarningsExact identifier
unii: L7T10EIP3A
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4e2a8b53-0074-42fd-8357-a39cc6afe6082026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackafdc6256-f7d0-404b-a377-328250ab29ff2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucus Relief Severe Cold Daytime Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET Corporation5ccaf3b0-096a-4644-9c6e-9f251c167b3c2026-03-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack68c97e24-6898-4c17-813b-e1e62f56cb652026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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