Home NDC 76519-1003 DOK EXTRA STRENGTH STOOL SOFTENER
Product NDC 76519-1003
11-digit product format 765191003
Labeler code 76519
Product ID 76519-1003_c92ab250-669c-4b29-945f-c6320a6a4edc
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2002-08-27
Marketing end 0000-00-00
Substance DOCUSATE SODIUM
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 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 76519-1003-6 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 76519-1003-6 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 76519-1003-6 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 76519-1003-6 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76519-1003-6 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76519-1003-6 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76519-1003-6 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76519-1003-6 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76519-1003-6 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76519-1003-6 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76519-1003-6 DOK EXTRA STRENGTH STOOL SOFTENER 60 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 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 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 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A 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 [H.J. HARKINS COMPANY, 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 [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76519-1003 DOK EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 1 package rows 20121031_8d71cd2c-a62b-4c40-8062-e9c986afb0b5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 76519-1003-6 76519100306 60 in 1 BOTTLE, PLASTIC Historical