Home NDC 49348-122-10 stool softener
Product NDC 49348-122
Requested package NDC 49348-122-10
11-digit product format 493480122
Labeler code 49348
Product ID 49348-122_f3e95e81-407b-4f13-a3d3-5f4b79bf841f
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE CALCIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Strategic Sourcing Services LLC
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-05-30
Marketing end 2021-12-30
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 [MCKESSON (SUNMARK)] 2 DOCUSATE ACTIVE MOIETY M7P27195AG STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 CORN OIL INACTIVE INGREDIENT 8470G57WFM STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)] 2
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 49348-122-10 49348012210 1 BOTTLE in 1 BOX (49348-122-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2014-05-30 2021-12-30 No No Current