FDA.reportPublic FDA data

NDC 0067-8162 - Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack

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
0067-8162
Package NDCs from labels
0067-8162-01
Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Theraflu Flu Relief Max Daytime - Haleon US Holdings LLCHaleon US Holdings LLC2024-03-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8162-01Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack20 in 1 BLISTER PACKTABLET2015 mg3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8162THERAFLU FLU RELIEF MAXIMUM STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]3Unmatched20240310_68d3e88a-d1be-410b-92a1-863903b3aa61.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 139 of 418 · 8,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART06574e56-13b8-a3af-e063-6394a90a48672025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART0668ddcc-0214-8e97-e063-6294a90a4f322025-12-22WarningsExact identifier
application number: M012
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
caring mill Cough drops CHERRYMENTHOLFSA STORE INC.9d666061-f7a8-4318-8db1-b65373689e1d2025-12-22WarningsExact identifier
application number: M012
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENGranules USA, Inca1255f60-b9c6-9a95-e053-2995a90a9e802025-12-22WarningsExact identifier
unii: 362O9ITL9D
Premier ValueCOUGH DROPS CHERRYPharmacy Value Alliance LLC018f4790-8785-94f4-e063-6394a90a19162025-12-22WarningsExact identifier
application number: M012
AcetaminophenACETAMINOPHENGranules USA, Inca51395ea-e038-dc9c-e053-2a95a90a287d2025-12-22WarningsExact identifier
unii: 362O9ITL9D
Premier ValueCOUGH DROPS HONEY LEMONPharmacy Value Alliance LLC0191fcf7-abc1-e583-e063-6294a90a78542025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLPharmacy Value Alliance LLC019211bf-dd4b-5f4c-e063-6294a90aacfb2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEPharmacy Value Alliance LLC018f20b1-06e0-eb13-e063-6394a90a5ec52025-12-22WarningsExact identifier
application number: M012
Quality Choice Cherry Cough DropsCHERRY COUGH DROPSChain Drug Marketing Association, Inc.6a407092-4b71-4156-b4ad-930782b5fb432025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Cough DropsHONEY LEMON COUGH DROPSChain Drug Marketing Association, Inc.1fd09b04-9c79-da20-e063-6394a90ae2632025-12-22WarningsExact identifier
application number: M012
Quality Choice Menthol Cough DropsMENTHOL COUGH DROPSChain Drug Marketing Association, Inc.3364470e-d9bb-42a6-9bd5-80c0bed8bc9e2025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Sugar Free Cough DropsHONEY LEMON SUGAR FREE COUGH DROPSChain Drug Marketing Association, Inc.1fd0a790-c67c-216f-e063-6294a90ae9712025-12-22WarningsExact identifier
application number: M012
CareALL AcetaminophenACETAMINOPHENNew World Imports, Inc1148b4d9-fa6a-49e6-9663-17b2c83738462025-12-22WarningsExact identifier
unii: 362O9ITL9D
CAREALL DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incf3b177ef-55d5-4525-bf33-99205c414a5b2025-12-22WarningsExact identifier
application number: M012
CAREALL Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incaf2f8389-d696-4060-8abd-6eda04e730092025-12-22WarningsExact identifier
application number: M012
VitapirenaACETAMINOPHENPharmadel LLC0547bc1f-d000-f5a6-e063-6294a90ac73d2025-12-22WarningsExact identifier
unii: 362O9ITL9D
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Incf818417e-0b31-4fe7-8313-4160a00b248a2025-12-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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