FDA.reportPublic FDA data

Promolaxin

Product NDC
63187-125
Requested package NDC
63187-125-00
11-digit product format
631870125
Labeler code
63187
Product ID
63187-125_68285586-9186-4ffb-9142-924001aed536
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-15
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-12563187-125-00DDiscontinued by firm2026-10-12

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 · 10 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-125-00EA - Each63187-12583758fac-ed05-4047-b10c-cd194f5ae50312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
DOCUSATEACTIVE MOIETYM7P27195AGPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-125-0063187012500100 TABLET in 1 BOTTLE (63187-125-00) 100 tablet2019-01-010000-00-00NoNoCurrent