FDA.reportPublic FDA data

Stool Softener Docusate Sodium

Product NDC
54257-902
11-digit product format
542570902
Labeler code
54257
Product ID
54257-902_08bf67ab-e837-2223-e063-6294a90a0878
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Magno-Humphries, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-04-04
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54257-902-06fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54257-902-0686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54257-902-06bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54257-902-068dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Docusate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0e6ab9b-fd31-45fd-93d5-b51d705c180aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54257-902-062023-10-29C16284748780-1ba0f9c33-2cdc-a910-e053-dadaa90a0b85Stool Softener Docusate Sodium
54257-902-062021-01-29C16284748780-1ba0f9c33-2cdc-a910-e053-dadaa90a0b85Stool Softener Docusate Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54257-902-02Stool Softener Docusate Sodium100 in 1 BOTTLECAPSULE, GELATIN COATED1006
54257-902-06Stool Softener Docusate Sodium1000 in 1 BOTTLECAPSULE, GELATIN COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54257-902-06EA - Each54257-9021b79f6cd-2f3a-4d3f-bbd4-66d8f726563212018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-902STOOL SOFTENER DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [MAGNO-HUMPHRIES, INC.]6Current NDC, Legacy NDC, 1 package rows20231030_9d22d642-8aed-d17e-e053-2995a90ae182.zip
54257-902STOOL SOFTENER DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [MAGNO-HUMPHRIES, INC.]5Current NDC, Legacy NDC, 1 package rows20231030_a0e6ab9b-fd31-45fd-93d5-b51d705c180a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
application number: M007
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
application number: M007
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
application number: M007
SennaSENNOSIDESProficient Rx LP5f7f0df4-dabe-4c8f-a2b5-766f20af2f462024-09-01WarningsExact identifier
application number: M007
Fiber caplets 147CALCIUM POLYCARBOPHILChain Drug Marketing Association Inc.17e2a50d-1867-49fe-e063-6394a90a56df2024-08-27WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVE PILLSSENNOSIDESTARGET CORPORATION7cae52ae-931c-3e7c-e053-2991aa0a83962024-08-22WarningsExact identifier
application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVEDOCUSATE SODIUM AND SENNOSIDESTARGET CORPORATION7cac99da-8d89-0aee-e053-2991aa0a0fd92024-08-22WarningsExact identifier
application number: M007
SENNA LAXATIVESENNOSIDES 8.6 MGTARGET CORPORATION7cab058f-3647-7124-e053-2a91aa0a41bd2024-08-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMProficient Rx LPccfa095c-77f0-41ff-84f8-e02d983c7c742024-08-01WarningsExact identifier
application number: M007
Magnesium CitrateHARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMONHarris Teeter, LLC1e8e01fc-2c89-9722-e063-6394a90a6acf2024-07-31WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESBest Choice (Valu Merchandisers Company)d5f90aa1-78e5-491f-b09d-399d54f3def12024-07-31WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESWalgreensbfa089a6-4767-45e0-b663-ee7e8949d9a42024-07-25WarningsExact identifier
application number: M007
Dr. FibraPSYLLIUM HUSKPharmadel LLC1a6151c9-e1c4-f0c1-e063-6394a90aad242024-07-22WarningsExact identifier
application number: M007
BISACODYLBISCODYLTARGET CORPORATION8ed281d5-b17e-e3bb-e053-2995a90a25902024-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreensb6f0770e-671d-4965-9275-b1c224d7f06a2024-07-10WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN9d22d642-8aed-d17e-e053-2995a90ae1826
1115005docusate sodium 100 MG Oral CapsuleSCD9d22d642-8aed-d17e-e053-2995a90ae1826
1115005DOSS Sodium 100 MG Oral CapsuleSY9d22d642-8aed-d17e-e053-2995a90ae1826
1115005docusate sodium 100 MG Oral CapsulePSNa0e6ab9b-fd31-45fd-93d5-b51d705c180a5
1115005docusate sodium 100 MG Oral CapsuleSCDa0e6ab9b-fd31-45fd-93d5-b51d705c180a5
1115005DOSS Sodium 100 MG Oral CapsuleSYa0e6ab9b-fd31-45fd-93d5-b51d705c180a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54257-902-0254257090202100 CAPSULE, GELATIN COATED in 1 BOTTLE (54257-902-02) 2020-01-240000-00-00NoNoCurrent
54257-902-06542570902061000 CAPSULE, GELATIN COATED in 1 BOTTLE (54257-902-06) 2017-04-04NoNoCurrent