Home NDC 0067-8137 Theraflu ExpressMax
Product NDC 0067-8137
11-digit product format 000678137
Labeler code 0067
Product ID 0067-8137_13185fea-1e12-cf5a-e063-6394a90a18af
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, diphenhydramine HCl, 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; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 12.5; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Nighttime Severe Cold and Cough
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 12.5 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 TC2D6JAD40 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 1233575 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-8137-10 Theraflu ExpressMaxNighttime Severe Cold and Cough 1 in 1 CARTON TABLET, FILM COATED 1 3 0067-8137-10 Theraflu ExpressMaxNighttime Severe Cold and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 0067-8137-20 Theraflu ExpressMaxNighttime Severe Cold and Cough 2 in 1 CARTON TABLET, FILM COATED 2 3 0067-8137-20 Theraflu ExpressMaxNighttime Severe Cold and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8137 THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 3 Current NDC, Legacy NDC, 4 package rows 20240308_62f7fcb9-e31a-4634-b1c2-44a9567e3a61.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 74 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 0067-8137-10 00067813710 1 BLISTER PACK in 1 CARTON (0067-8137-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-06-08 0000-00-00 No No Current 0067-8137-20 00067813720 2 BLISTER PACK in 1 CARTON (0067-8137-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2016-07-05 0000-00-00 No No Current