Home NDC 0904-7891 DOK EXTRA STRENGTH STOOL SOFTENER
Product NDC 0904-7891
11-digit product format 009047891
Labeler code 0904
Product ID 0904-7891_b9eaaa09-9808-428d-8bb4-0c37371bce96
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Major Pharmaceuticals
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2002-08-27
Marketing end 2019-12-31
Substance DOCUSATE SODIUM
Active strength 250 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 0904-7891-59 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 DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 DOCUSATE ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 GELATIN INACTIVE INGREDIENT 2G86QN327L DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 WATER INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 DOCUSATE ACTIVE MOIETY M7P27195AG DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 DOCUSATE ACTIVE MOIETY M7P27195AG DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 DOCUSATE ACTIVE MOIETY M7P27195AG DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.] 1
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