Home NDC 51013-111 STOOL SOFTENER DOCUSATE SODIUM 50 MG
Product NDC 51013-111
11-digit product format 510130111
Labeler code 51013
Product ID 51013-111_d5285de6-d5e0-4571-a0e8-4864c5396984
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler PuraCap Pharmaceutical LLC
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-08-22
Marketing end 0000-00-00
Substance DOCUSATE SODIUM
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51013-111-24 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51013-111-20 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51013-111-24 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51013-111-20 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51013-111-24 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51013-111-20 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51013-111-24 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51013-111-20 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51013-111-24 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51013-111-20 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51013-111-24 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51013-111-20 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51013-111-20 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51013-111-24 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51013-111-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51013-111-24 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51013-111-20 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51013-111-24 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 51013-111-20 STOOL SOFTENER DOCUSATE SODIUM 50 MG 30 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 30 3 51013-111-20 STOOL SOFTENER DOCUSATE SODIUM 50 MG 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 51013-111-24 STOOL SOFTENER DOCUSATE SODIUM 50 MG 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 51013-111-24 STOOL SOFTENER DOCUSATE SODIUM 50 MG 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 DOCUSATE ACTIVE MOIETY M7P27195AG STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-111 STOOL SOFTENER DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 3 Legacy NDC, 4 package rows 20191211_efdd022f-7971-4875-a6a8-fa3d1dce9c9c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51013-111-20 51013011120 1 BOTTLE, PLASTIC in 1 CARTON (51013-111-20) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2014-08-22 0000-00-00 No No Current 51013-111-24 51013011124 1 BOTTLE, PLASTIC in 1 CARTON (51013-111-24) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2014-08-22 0000-00-00 No No Current