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 131 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag b790a91c-33be-4bc3-bdeb-eae6f366f085 2024-12-05 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola Ag ea42e516-2ef8-41c9-ae4e-571f0147bc6b 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola Ag 8b2d5c0f-509e-447d-b071-d73c4785f120 2024-12-05 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola Ag 8ae0e21a-44a0-4a2c-9880-54eeeaea07ea 2024-12-05 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 6d82469b-d51c-4824-9830-6c1874ad4fe4 2024-12-05 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola Ag e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag a535717d-ba55-45e9-9fc3-711b5d7dbf57 2024-12-05 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola Ag 4330ee8d-0b37-4a93-886b-5fc6e6598da7 2024-12-05 Warnings Exact identifier application number: M012
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