FDA.reportPublic FDA data

Docusate Sodium

Product NDC
0121-0544
11-digit product format
001210544
Labeler code
0121
Product ID
0121-0544_b943532e-9ad6-9470-e053-2995a90af9f1
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1983-02-16
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct0121-0544DDiscontinued by firm2026-08-11
excluded packagepackage0121-05440121-0544-10DDiscontinued by firm2026-08-11
excluded packagepackage0121-05440121-0544-16DDiscontinued by firm2026-08-11
excluded packagepackage0121-05440121-0544-25DDiscontinued 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 packagepackage0121-0544-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0544-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0544-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-0544-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-0544-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-0544-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-0544-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-0544-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-0544-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-0544-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-0544-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-0544-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-0544-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-0544-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-0544-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-0544-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-0544-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-0544-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-0544-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-0544-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-0544-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-0544-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-0544-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-0544-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-0544-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-0544-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-0544-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-0544-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-0544-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-0544-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-0544-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-0544-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-0544-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0121-0544-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0121-0544-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0121-0544-16557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0544-10ML - Milliliter0121-054440512368-e5ba-4acf-908d-c9b1ea0ac09512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM LIQUID [CARDINAL HEALTH]3
Docusate SodiumACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
DocusateACTIVE MOIETYM7P27195AGDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0544-100012105441010 TRAY in 1 CASE (0121-0544-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE10 tray1983-02-160000-00-00NoNoCurrent
0121-0544-160012105441612 BOTTLE in 1 CASE (0121-0544-16) > 473 mL in 1 BOTTLE12 bottle1983-02-160000-00-00NoNoCurrent
0121-0544-250012105442510 TRAY in 1 CASE (0121-0544-25) > 10 CUP, UNIT-DOSE in 1 TRAY > 25 mL in 1 CUP, UNIT-DOSE10 tray1983-02-160000-00-00NoNoCurrent