FDA.reportPublic FDA data

Phillips Stool Softener

Product NDC
0280-1012
Requested package NDC
0280-1012-30
11-digit product format
002801012
Labeler code
0280
Product ID
0280-1012_4523911f-9d9b-4b0c-e063-6394a90ac76d
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-02
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0280-10120280-1012-30DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0280-10120280-1012-30DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Phillips Stool Softener
Brand name suffix
Bulk Docusate
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup
1248002Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0462555-5554-4a17-a1fe-4206a4fd350dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-1012-30Phillips Stool SoftenerBulk Docusate30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3014
0280-1012-30Phillips Stool SoftenerBulk Docusate1 in 1 CARTONCAPSULE, LIQUID FILLED114
0280-1012-60Phillips Stool SoftenerBulk Docusate1 in 1 CARTONCAPSULE, LIQUID FILLED114
0280-1012-60Phillips Stool SoftenerBulk Docusate60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED6014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
DOCUSATEACTIVE MOIETYM7P27195AGPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
GELATININACTIVE INGREDIENT2G86QN327LPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
SHELLACINACTIVE INGREDIENT46N107B71OPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2
WATERINACTIVE INGREDIENT059QF0KO0RPHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-1012PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]13Current NDC, Legacy NDC, 4 package rows20241027_b0462555-5554-4a17-a1fe-4206a4fd350d.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 1 of 44 · 872 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-05WarningsExact identifier
application number: M007
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-04WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb0462555-5554-4a17-a1fe-4206a4fd350d14
1248002Phillips' Stool Softener 100 MG Oral CapsulePSNb0462555-5554-4a17-a1fe-4206a4fd350d14
1248002docusate sodium 100 MG Oral Capsule [Phillips Stool Softener]SBDb0462555-5554-4a17-a1fe-4206a4fd350d14
1115005docusate sodium 100 MG Oral CapsuleSCDb0462555-5554-4a17-a1fe-4206a4fd350d14
1115005DOSS Sodium 100 MG Oral CapsuleSYb0462555-5554-4a17-a1fe-4206a4fd350d14
1248002DOSS Sodium 100 MG Oral Capsule [Phillips Stool Softener]SYb0462555-5554-4a17-a1fe-4206a4fd350d14
1248002Phillips Stool Softener 100 MG Oral CapsuleSYb0462555-5554-4a17-a1fe-4206a4fd350d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0280-1012-30002801012301 BOTTLE, PLASTIC in 1 CARTON (0280-1012-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2015-05-192023-12-01NoNoCurrent