Home NDC 54838-209-70 Siltussin DM
Product NDC 54838-209
Requested package NDC 54838-209-70
11-digit product format 548380209
Labeler code 54838
Product ID 54838-209_39e6fbaa-ce27-41ba-bb09-e86e363da87f
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 1992-09-05
Marketing end 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 Dextromethorphan ACTIVE MOIETY 7355X3ROTS SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 menthol INACTIVE INGREDIENT L7T10EIP3A SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 sucrose INACTIVE INGREDIENT C151H8M554 SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 water INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [SILARX PHARMACEUTICALS,INC] 16 Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 Dextromethorphan ACTIVE MOIETY 7355X3ROTS SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 citric acid INACTIVE INGREDIENT 2968PHW8QP SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 menthol INACTIVE INGREDIENT L7T10EIP3A SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 sucrose INACTIVE INGREDIENT C151H8M554 SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 water INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PREFERRED PHARMACEUTICALS, INC] 10 Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 Dextromethorphan ACTIVE MOIETY 7355X3ROTS SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [TYA PHARMACEUTICALS] 2 Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 citric acid INACTIVE INGREDIENT 2968PHW8QP TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 menthol INACTIVE INGREDIENT L7T10EIP3A TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R TUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [PHYSICIANS TOTAL CARE, INC.] 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 54838-209-70 54838020970 237 mL in 1 BOTTLE, PLASTIC (54838-209-70) 237 ml 1992-09-05 2023-11-30 No No Current