Home NDC 63868-116-25 Stool Softener
Product NDC 63868-116
Requested package NDC 63868-116-25
11-digit product format 638680116
Labeler code 63868
Product ID 63868-116_776f6fc5-8944-4f26-a45d-41b7e8d35763
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-11-30
Marketing end 2022-12-30
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 · 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 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 [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 DOCUSATE ACTIVE MOIETY M7P27195AG STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-116-25 63868011625 250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (63868-116-25) 2013-11-30 2022-12-30 No No Current