Home NDC 54838-107-80 Silace
Product NDC 54838-107
Requested package NDC 54838-107-80
11-digit product format 548380107
Labeler code 54838
Product ID 54838-107_64c30d40-a28c-42c1-8810-910609ffc75f
Type HUMAN OTC DRUG
Nonproprietary name Docusate sodium
Dosage form SYRUP
Route ORAL
Labeler Lannett Company, Inc.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1990-03-05
Marketing end 0000-00-00
Substance DOCUSATE SODIUM
Active strength 60 mg/15mL
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 · 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 Docusate sodium ACTIVE INGREDIENT F05Q2T2JA0 SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 Docusate ACTIVE MOIETY M7P27195AG SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 alcohol INACTIVE INGREDIENT 3K9958V90M SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 D&C red no. 33 INACTIVE INGREDIENT 9DBA0SBB0L SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 sucrose INACTIVE INGREDIENT C151H8M554 SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 water INACTIVE INGREDIENT 059QF0KO0R SILACE (DOCUSATE SODIUM) SYRUP [SILARX PHARMACEUTICALS,INC] 14 Docusate sodium ACTIVE INGREDIENT F05Q2T2JA0 SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 Docusate ACTIVE MOIETY M7P27195AG SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 citric acid INACTIVE INGREDIENT 2968PHW8QP SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 D&C red no. 33 INACTIVE INGREDIENT 9DBA0SBB0L SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 SILACE (DOCUSATE SODIUM) SYRUP [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R SILACE (DOCUSATE SODIUM) SYRUP [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 54838-107-80 54838010780 473 mL in 1 BOTTLE, PLASTIC (54838-107-80) 473 ml 1990-03-05 0000-00-00 No No Current