Home NDC 0536-1065-10 Stool Softener
Product NDC 0536-1065
Requested package NDC 0536-1065-10
11-digit product format 005361065
Labeler code 0536
Product ID 0536-1065_85bad6d2-5e32-470d-9f58-7285b90c454e
Type HUMAN OTC DRUG
Nonproprietary name Docusate calcium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Rugby Laboratories, Inc.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-01-31
Marketing end 2024-02-23
Substance DOCUSATE CALCIUM
Active strength 240 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 CALCIUM ACTIVE INGREDIENT 6K7YS503HC STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 DOCUSATE ACTIVE MOIETY M7P27195AG STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 CORN OIL INACTIVE INGREDIENT 8470G57WFM STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0536-1065-10 00536106510 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1065-10) 2015-01-31 2024-02-23 No No Current