Home NDC 54838-133 Siltussin DM DAS Cough Formula
Product NDC 54838-133
11-digit product format 548380133
Labeler code 54838
Product ID 54838-133_77e74ca8-1539-444b-b810-3115b3a8a154
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Dextromethorphan Hydrobromide
Dosage form LIQUID
Route ORAL
Labeler Lannett Company, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1995-09-05
Marketing end 2024-03-31
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10 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 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 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 54838-133-40 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 Dextromethorphan ACTIVE MOIETY 7355X3ROTS SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 menthol INACTIVE INGREDIENT L7T10EIP3A SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 sorbitol INACTIVE INGREDIENT 506T60A25R SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 water INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 14 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [LLC FEDERAL SOLUTIONS] 1
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 54838-133-40 54838013340 118 mL in 1 BOTTLE, PLASTIC (54838-133-40) 118 ml 1995-09-05 2024-03-31 No No Current