Home NDC 54838-140 Diabetic Maximum Strength Siltussin DM DAS-Na
Product NDC 54838-140
11-digit product format 548380140
Labeler code 54838
Product ID 54838-140_c723bfab-3297-4b37-82ec-9bbd11e124b8
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 2005-11-05
Marketing end 0000-00-00
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 54838-140-40 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 DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Guaifenesin ACTIVE INGREDIENT 495W7451VQ DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Dextromethorphan ACTIVE MOIETY 7355X3ROTS DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 Guaifenesin ACTIVE MOIETY 495W7451VQ DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 aspartame INACTIVE INGREDIENT Z0H242BBR1 DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 benzoic acid INACTIVE INGREDIENT 8SKN0B0MIM DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 HYPROMELLOSE 2910 (4000 MPA.S) INACTIVE INGREDIENT RN3152OP35 DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 methylparaben INACTIVE INGREDIENT A2I8C7HI9T DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12 water INACTIVE INGREDIENT 059QF0KO0R DIABETIC MAXIMUM STRENGTH SILTUSSIN DM DAS-NA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS, INC] 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-140-40 54838014040 118 mL in 1 BOTTLE, PLASTIC (54838-140-40) 118 ml 2005-11-05 0000-00-00 No No Current