DulcoEase Pink

Product NDC
0597-0151
11-digit product format
005970151
Labeler code
0597
Product ID
0597-0151_9933da94-247d-8e68-c48b-b1ab5045b678
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-01
Marketing end
2021-11-30
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0597-0151DDiscontinued by firm2026-08-11
excluded packagepackage0597-01510597-0151-23DDiscontinued by firm2026-08-11
excluded packagepackage0597-01510597-0151-30DDiscontinued by firm2026-08-11
excluded packagepackage0597-01510597-0151-64DDiscontinued by firm2026-08-11

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0151-23d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0151-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0151-64d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0151-23f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0151-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0151-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0151-232ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0151-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0151-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0151-23a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0151-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0151-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0151-23cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0151-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0151-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0151-23cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0151-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0151-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0151-23302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0151-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0151-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0151-23ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0151-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0151-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0151-230efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0151-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0151-640efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0151-23ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0151-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0151-64ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0151-23367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0151-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0151-64367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0151-23557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0151-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0151-64557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
DOCUSATEACTIVE MOIETYM7P27195AGDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDULCOEASE PINK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0151-23005970151231 BOTTLE in 1 CARTON (0597-0151-23) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2013-02-012021-11-30NoNoCurrent
0597-0151-30005970151301 BOTTLE in 1 CARTON (0597-0151-30) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2013-02-012021-11-30NoNoCurrent
0597-0151-64005970151641 BOTTLE in 1 CARTON (0597-0151-64) > 38 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2013-02-012021-11-30NoNoCurrent