Home NDC 54859-801-60 Tusnel
Product NDC 54859-801
Requested package NDC 54859-801-60
11-digit product format 548590801
Labeler code 54859
Product ID 54859-801_732630f4-d829-4cab-8834-74ce18a6f145
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl
Dosage form TABLET
Route ORAL
Labeler LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-07-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54859-801-60 54859080160 60 TABLET in 1 BOTTLE (54859-801-60) 60 tablet 2007-07-01 0000-00-00 No No Current