Home NDC 68196-238 Stool Softener
Product NDC 68196-238
11-digit product format 681960238
Labeler code 68196
Product ID 68196-238_e566966f-8775-4285-9133-e9a2b1d7e8e7
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Sam's West, Inc
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-05-31
Marketing end 2021-12-30
Substance DOCUSATE SODIUM
Active strength 100 mg/1
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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 68196-238-06 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 DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 DOCUSATE ACTIVE MOIETY M7P27195AG STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68196-238-06 68196023806 600 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68196-238-06) 2015-05-31 2021-12-30 No No Current