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 126 of 418 · 8,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Llorens Care TussinGUAIFENESINLlorens Pharmaceutical International Division, Inc.474459c1-bfd7-dec7-e063-6394a90ac18d2025-12-31WarningsExact identifier
application number: M012
Geri Care Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICAL CORP4744669c-7f33-e35f-e063-6394a90a79b72025-12-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4744e501-f12a-6d25-e063-6394a90a25742025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp65545ca3-4e93-4b59-9e17-4742e086e8e72025-12-31WarningsExact identifier
application number: M012
GeriCare Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICALS, CORP47451cd8-7aab-90e2-e063-6394a90ad1b72025-12-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Curewell TussinGUAIFENESINRMT HEALTH LLC47455587-5074-e70d-e063-6294a90a78bb2025-12-31WarningsExact identifier
application number: M012
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47456bf5-9f6c-e6a5-e063-6294a90a70542025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
unii: 362O9ITL9D
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ab56-abaa-42de-e063-6394a90a63102025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Menthol Cough DropsMENTHOLBestco Inc.77e25027-3c96-21fa-e053-2991aa0a1f312025-12-31WarningsExact identifier
application number: M012
Puregen Labs Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC4745d4f9-bbdf-a4a6-e063-6294a90a15b22025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2a46ea9b-29e9-5197-e063-6394a90abc732025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77e50410-306d-b2fb-e053-2a91aa0af3c52025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONe086a6d2-f664-454e-9524-f656bfbf45df2025-12-31WarningsExact identifier
application number: M012
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ebec-acb0-77c4-e063-6394a90aee072025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Cherry Cough DropsMENTHOLBestco Inc.77f45efb-8ee0-1186-e053-2991aa0a98842025-12-31WarningsExact identifier
application number: M012
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
application number: M012
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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