Home NDC 54859-520 Tusnel
Product NDC 54859-520
11-digit product format 548590520
Labeler code 54859
Product ID 54859-520_3ba8cde8-85c8-4c33-a66c-aacc26fb6146
Type HUMAN OTC DRUG
Nonproprietary name Codeine Phosphate, Guiafenesin, Pseudoephedrine HCl
Dosage form LIQUID
Route ORAL
Labeler Llorens Pharmaceutical International Division
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1995-01-01
Marketing end 0000-00-00
Substance CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 10 mg/5mL; mg/5mL; mg/5mL
DEA schedule CV
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 · 4 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 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54859-520-16 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54859-520-16 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 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 Guaifenesin ACTIVE INGREDIENT 495W7451VQ TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 Guaifenesin ACTIVE MOIETY 495W7451VQ TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-520 TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 4 Legacy NDC 20241222_403935ac-5111-4f8b-80ae-1bd47ae774c7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54859-520-16 54859052016 473 mL in 1 BOTTLE (54859-520-16) 473 ml 1995-01-01 0000-00-00 No No Current