Home NDC 54859-505 Tusnel Diabetic
Product NDC 54859-505
11-digit product format 548590505
Labeler code 54859
Product ID 54859-505_471f18f8-553e-41f9-e063-6394a90ae51e
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2003-12-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 54859-505-16 e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54859-505-04 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 54859-505-16 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54859-505-04 9bebd1f3094a…5416666fcb17…
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 Tusnel Diabetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 54859-505-04 Tusnel Diabetic 118 mL in 1 BOTTLE LIQUID 118 7 54859-505-16 Tusnel Diabetic 472 mL in 1 BOTTLE LIQUID 472 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-505 TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 6 Current NDC, Legacy NDC, 2 package rows 20241225_66b3c094-809e-4d2c-bc15-46563de685cb.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 54859-505-04 54859050504 118 mL in 1 BOTTLE (54859-505-04) 118 ml 2003-12-01 0000-00-00 No No Current 54859-505-16 54859050516 472 mL in 1 BOTTLE (54859-505-16) 472 ml 2003-12-01 0000-00-00 No No Current