FDA.reportPublic FDA data

NDC 72288-591 - basic care daytime severe cold and flu nighttime severe cold cough 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
72288-591
Package NDCs from labels
72288-591-91
Manufacturer
Amazon.com Services LLC
Effective date
2024-10-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
basic care daytime severe cold and flu - Amazon.com Services LLCAmazon.com Services LLC2024-10-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-591-91basic care daytime severe cold and flu nighttime severe cold cough and flu1 in 1 PACKETPOWDER, FOR SOLUTION6650 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-591BASIC CARE DAYTIME SEVERE COLD AND FLU NIGHTTIME SEVERE COLD COUGH AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE) KIT [AMAZON.COM SERVICES LLC]2Unmatched20241013_f65ab142-fa29-4cbc-a81c-fd32cf2c639e.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 170 of 293 · 5,846 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENGland Pharma Limiteddb5d4cf8-762a-4111-971e-91c704bc36432025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHEN 500MGCVS Pharmacy, Inc.1fde6487-6682-99a3-e063-6294a90a36702025-04-04WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN AND IBUPROFENDr. Reddy's Labortories Inc3e65c8a3-498e-1a2a-bb76-18e28ae2c73c2025-04-04WarningsExact identifier
unii: 362O9ITL9D
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.829bbcbf-fb27-4484-aff6-a7e7467670af2025-04-03Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Sleep AidDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)25f32a1c-0687-45e9-8142-96cf635990902025-04-03WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLC6d1aa0e2-036d-4382-a458-fc0300dba7cb2025-04-03Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.31d24067-3c25-0f1a-e063-6394a90a9f1d2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
dextromethorphan polistirex extended releaseDEXTROMETHORPHAN POLISTIREXBryant Ranch Prepackbd415342-90e1-411b-b6c9-652e9532c6112025-04-02WarningsExact identifier
unii: 9D2RTI9KYH
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEAlcon Laboratories, Inc.cacbb3fd-1c03-4523-a1bf-0ccc4be102ef2025-04-01Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
AcetaminophenACETAMINOPHENProficient Rx LP9af5ccc8-aac0-4339-a9f6-58fdc9b91c572025-04-01WarningsExact identifier
unii: 362O9ITL9D
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: 04JA59TNSJ
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
unii: 362O9ITL9D
Sleep AidDIPHENHYDRAMINE HCLFSA Store Inc. (Caring Mills)9d32a3a1-9528-4de4-9fd1-1d01a1ad93e92025-03-28WarningsExact identifier
unii: TC2D6JAD40
Infants Pain and FeverACETAMINOPHENWALGREENS281a530b-c759-50eb-e063-6394a90abb4f2025-03-28WarningsExact identifier
unii: 362O9ITL9D
Diphenhydramine HCLDIPHENHYDRAMINE HCLBryant Ranch Prepack59aeb692-2f79-45aa-8e6a-dab77cd3b2f92025-03-28WarningsExact identifier
unii: TC2D6JAD40
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWR Group, Inc.8281771c-485c-42a9-9a1c-9a7a4298c5b82025-03-28WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
Nighttime Sleep AidDIPHENHYDRAMINE HCLWR Group, Inc.d28d0f6d-8029-4e31-b417-4f8f864d840e2025-03-28WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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