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 143 of 294 · 5,865 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Incfb6fce1e-2dea-485c-be18-c6764454fe252025-09-26WarningsExact identifier
unii: 9D2RTI9KYH
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
AMAZON BASIC CARE MUCUS DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAmazon.com Services LLC10eda178-a9cf-685c-e063-6294a90ae5ec2025-09-25WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: 04JA59TNSJ
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
unii: 9D2RTI9KYH
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
unii: TC2D6JAD40
Xpect Pain Away Extra StrengthACETAMINOPHEN ASPIRIN CAFFEINECintas Corporation1269d069-afaf-4ca5-b369-f74249a348db2025-09-24WarningsExact identifier
unii: 362O9ITL9D
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
unii: 9D2RTI9KYH
AcetaminophenACETAMINOPHENProPharma Distribution3f7a6fdc-6e36-dc3e-e063-6394a90a067d2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECosette Pharmaceuticals, Inc.e7b336d9-b1df-4a08-9b67-754346d365f42025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPadagis US LLC06db369d-09fe-4ca2-b98c-705356b7c4032025-09-23Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions87f9e9fb-5433-478b-9f23-e16883a9d2a92025-09-23Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
unii: 9D2RTI9KYH
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Vax-SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICANutritional Specialties, Inc.cd570e98-c73f-4b38-b5b9-9f16f745ca192025-09-22WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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