FDA.reportPublic FDA data

NDC 79481-0807-04 - meijer Daytime and Nighttime Cold and Flu 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
79481-0807
Requested NDC
79481-0807-04
Package NDCs from labels
79481-0807-4, 79481-0807-04
Manufacturer
Meijer, Inc.
Effective date
2024-09-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
meijer Daytime and Nighttime Cold & Flu SOFTGELMeijer, Inc.2024-09-19HUMAN OTC DRUG LABEL
meijer Daytime Cold & Flu SOFTGELMeijer, Inc.2024-09-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0807-4meijer Daytime Cold and Flu SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED22
79481-0807-4meijer Daytime Cold and Flu SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0807MEIJER DAYTIME COLD AND FLU SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MEIJER, INC.]2Current NDC, 2 package rows20240921_1bdd7f8a-93ce-5309-e063-6294a90a91f0.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 171 of 326 · 6,507 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEAdvanced Rx LLCa7ed4c76-a5b5-44f7-866f-f43790e45c782025-09-18WarningsExact identifier
unii: 362O9ITL9D
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact identifier
application number: M012
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
acetaminophenACETAMINOPHENCVS Pharmacyfc2d4367-8884-4b76-aa3e-8c35be1ace492025-09-18WarningsExact identifier
unii: 362O9ITL9D
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEGland Pharma Limited2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb2025-09-18Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Cold and Flu Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b2025-09-17WarningsExact identifier
application number: M012
rxcui: 1086997
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCab02080a-c903-4e4a-a9f3-2b8197ed2f2b2025-09-17WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC79669930-f744-4bb1-8325-b75951489b642025-09-17WarningsExact identifier
unii: 362O9ITL9D
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
AXIV DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC1872e1ff-2e08-c404-e063-6294a90afa142025-09-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
AXIV Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC186f8519-655d-bd21-e063-6294a90a16a82025-09-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
AXIV NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC131f6314-c9a1-7af3-e063-6294a90abe6f2025-09-17WarningsExact identifier
application number: M012
rxcui: 1094549
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
AXIV DayTime - NightTime 48 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC1320e243-344f-98ed-e063-6294a90a00922025-09-17WarningsExact identifier
application number: M012
rxcui: 1094549
AXIV Sinus Severe MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDEVIVUNT PHARMA LLC13245298-8b78-e177-e063-6294a90a6bec2025-09-17WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
GoodSense Tussin CF Multi-Symptom Cold, RaspberryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.3f05cf84-d485-7688-e063-6394a90ae7402025-09-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)5d7466b4-fdb7-432b-880d-e7aa4a4acbda2025-09-17WarningsExact identifier
application number: M012
rxcui: 1086997
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
allergy relief ChildrensDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIe34d8bf5-e12e-453c-93ea-9c7988c4f13d2025-09-16WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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