Home NDC 0067-8125 Theraflu ExpressMax
Product NDC 0067-8125
11-digit product format 000678125
Labeler code 0067
Product ID 0067-8125_15beba82-bd3d-a666-e063-6394a90a8867
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form KIT
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-15
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Theraflu ExpressMax
Brand name suffix Daytime Nighttime Value Pack
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1113705 Internal RxNorm lookup 1298348 Internal RxNorm lookup 1803669 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-8125-16 Theraflu ExpressMaxDaytime Nighttime Value Pack 1 in 1 CARTON KIT 1 5 0067-8127-08 Theraflu ExpressMaxDaytime Nighttime Value Pack 245.5 mL in 1 BOTTLE SYRUP 245.5 mL 650 mg in 30mL 5 0067-8129-08 Theraflu ExpressMaxDaytime Nighttime Value Pack 245.5 mL in 1 BOTTLE SYRUP 245.5 mL 650 mg in 30mL 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8125 THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 3 package rows 20240411_9736ad4c-8c2e-421f-b023-f91b72d2828b.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 73 of 178 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0067-8125-16 00067812516 1 KIT in 1 CARTON (0067-8125-16) * 245.5 mL in 1 BOTTLE (0067-8127-08) * 245.5 mL in 1 BOTTLE (0067-8129-08) 1 kit 2015-07-15 0000-00-00 No No Current 0067-8127-08 00067812708 245.5 mL in 1 BOTTLE 245.5 ml Historical 0067-8129-08 00067812908 245.5 mL in 1 BOTTLE 245.5 ml Historical