Home NDC 54838-117-80 Siltussin SA
Product NDC 54838-117
Requested package NDC 54838-117-80
11-digit product format 548380117
Labeler code 54838
Product ID 54838-117_0c91f982-f8fd-450c-86eb-3f49f4ef11d5
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Lannett Company, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1998-10-05
Marketing end 2024-12-31
Substance GUAIFENESIN
Active strength 100 mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 · 9 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…
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 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 sorbitol INACTIVE INGREDIENT 506T60A25R SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 water INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN SA (GUAIFENESIN) LIQUID [SILARX PHARMACEUTICALS, INC] 15 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 sorbitol INACTIVE INGREDIENT 506T60A25R SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1 sorbitol INACTIVE INGREDIENT 506T60A25R SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 water INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN SA (GUAIFENESIN) LIQUID [PROFICIENT RX LP] 1 water INACTIVE INGREDIENT 059QF0KO0R SILTUSSIN SA (GUAIFENESIN) LIQUID [PREFERRED PHARMACEUTICALS, INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-117-80 54838011780 473 mL in 1 BOTTLE, PLASTIC (54838-117-80) 473 ml 1998-10-05 2024-11-30 No No Current