Home NDC 0067-8136 Theraflu ExpressMax
Product NDC 0067-8136
11-digit product format 000678136
Labeler code 0067
Product ID 0067-8136_1317707c-219d-678a-e063-6294a90a142e
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-05
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Severe Cold and Cough
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094538 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 0067-8136-10 Theraflu ExpressMaxDaytime Severe Cold and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 5 0067-8136-10 Theraflu ExpressMaxDaytime Severe Cold and Cough 1 in 1 CARTON TABLET, FILM COATED 1 5 0067-8136-20 Theraflu ExpressMaxDaytime Severe Cold and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 5 0067-8136-20 Theraflu ExpressMaxDaytime Severe Cold and Cough 2 in 1 CARTON TABLET, FILM COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8136 THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 4 package rows 20240308_f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7.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 98 of 180 · 3,583 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 0067-8136-10 00067813610 1 BLISTER PACK in 1 CARTON (0067-8136-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-06-08 0000-00-00 No No Current 0067-8136-20 00067813620 2 BLISTER PACK in 1 CARTON (0067-8136-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2016-07-05 0000-00-00 No No Current