Home NDC 0067-8131 Theraflu ExpressMax
Product NDC 0067-8131
11-digit product format 000678131
Labeler code 0067
Product ID 0067-8131_f7236180-31a7-4292-b21c-29f95136a82e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form SYRUP
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-15
Marketing end 2020-09-30
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0067-8131-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0067-8131-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0067-8131-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0067-8131-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0067-8131-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0067-8131-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0067-8131-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0067-8131-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0067-8131-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0067-8131-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0067-8131-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0067-8131-08 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 MALTITOL INACTIVE INGREDIENT D65DG142WK THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R THERAFLU EXPRESSMAX FLU, COUGH, AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.] 2