FDA.reportPublic FDA data

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Product NDC
0603-0150
Requested package NDC
0603-0150-21
11-digit product format
006030150
Labeler code
0603
Product ID
0603-0150_ad899d1e-923e-45bf-ba15-cb424a440e8f
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-08-01
Marketing end
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0603-01500603-0150-21DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-0150-21EA - Each0603-01505dada3d0-13c6-4410-93ee-8dc33cc7d42a12013-02-13
0603-0150-32EA - Each0603-015073a170ce-3ec9-4aad-a86b-13acad0ac4ec12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM TABLET [DIRECT RX]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM TABLET [DIRECT RX]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM TABLET [DIRECT RX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM TABLET [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM TABLET [DIRECT RX]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM TABLET [DIRECT RX]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDOCUSATE SODIUM TABLET [DIRECT RX]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM TABLET [DIRECT RX]2
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM TABLET [DIRECT RX]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RDOCQLACE (DOCUSATE SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RDOCQLACE (DOCUSATE SODIUM) CAPSULE [QUALITEST PHARMACEUTICALS]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099279docusate sodium 100 MG Oral TabletPSN014d2ea7-e704-477a-8616-6bce2d9ea1622
1099279docusate sodium 100 MG Oral TabletSCD014d2ea7-e704-477a-8616-6bce2d9ea1622
1099279DOSS Sodium 100 MG Oral TabletSY014d2ea7-e704-477a-8616-6bce2d9ea1622
1115005docusate sodium 100 MG Oral CapsulePSN35d8edf9-e296-474e-a650-977c40b5e82e1
1115005docusate sodium 100 MG Oral CapsuleSCD35d8edf9-e296-474e-a650-977c40b5e82e1
1115005DOSS Sodium 100 MG Oral CapsuleSY35d8edf9-e296-474e-a650-977c40b5e82e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-0150-2100603015021100 CAPSULE in 1 BOTTLE, PLASTIC (0603-0150-21) 100 capsule2011-08-012021-10-31NoNoCurrent