FDA.reportPublic FDA data

Docusate Sodium

Product NDC
0121-0935
11-digit product format
001210935
Labeler code
0121
Product ID
0121-0935_5cfc4685-c885-4303-a988-5009cbd8e57b
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-16
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage0121-09350121-0935-16DDiscontinued by firm2026-10-16

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 · 1 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-09350121-0935-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Docusate Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/5mL

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
1245686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0935-05Docusate Sodium5 mL in 1 CUP, UNIT-DOSELIQUID59
0121-0935-16Docusate Sodium473 mL in 1 BOTTLELIQUID4739
0121-0935-40Docusate Sodium10 in 1 TRAYLIQUID109
0121-0935-40Docusate Sodium4 in 1 CASELIQUID49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0935-05ML - Milliliter0121-0935bd4be1fb-4d63-4e7c-8bfa-2e34cd4de1c512021-10-08
0121-0935-16ML - Milliliter0121-09353bdd2684-e7df-4efc-abb2-b74bbcf7d51612021-10-08
0121-0935-40ML - Milliliter0121-09353327600b-3340-46f6-b2a4-f6be1a4545bb12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0935DOCUSATE SODIUM LIQUID [PAI HOLDINGS, LLC DBA PAI PHARMA]9Current NDC, Legacy NDC, 4 package rows20250216_e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5.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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEPreferred Pharmaceuticals Inc.f8bba8cb-a111-4285-8bdb-2273a049c3bb2026-07-08WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
application number: M007
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
application number: M007
SennaSENNOSIDES 8.6 MG TABLETSAarkish Pharmaceuticals NJ Inc.564bc9a5-13b5-4cce-a349-6b2e122683ed2026-07-01WarningsExact identifier
application number: M007
Senna-SDOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MGAarkish Pharmaceuticals NJ Inc.faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f2026-07-01WarningsExact identifier
application number: M007
ENEMEEZDOCUSATE SODIUMQuest Products, LLC0b06445d-0839-497e-bdff-e0fe224a77382026-06-30WarningsExact identifier
application number: M007
ENEMEEZ PlusDOCUSATE SODIUM AND BENZOCAINEQuest Products, LLC1670ca59-7275-4ac6-bef4-674a7b24c7b32026-06-30WarningsExact identifier
application number: M007
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens20c43036-830b-0e1d-e063-6394a90adf5f2026-06-25WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packagingbe7cab51-ce7e-465d-95db-083e69288cfd2026-06-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEVi-Jon, LLCba490c22-19f0-4887-9509-bd3d32e0f5b12026-06-24Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEKROGER COMPANYa1b0c638-6c34-1b72-e053-2995a90acc852026-06-24WarningsExact identifier
application number: M007
Womens LaxativeWOMENS LAXTIVEAllegiant Health549a11d1-a096-4c22-96b4-2d4f54f460222026-06-24WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf4259fda-19d4-087e-e053-2995a90a70812026-06-22WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMGeri-Care Pharmaceuticals, Corp3ec42148-6786-22f2-e054-00144ff8d46c2026-06-18WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
application number: M007
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSNe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 10 MG/ML Oral SolutionSCDe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 10 MG per 1 ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 100 MG per 10 ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 150 MG per 15 ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686DOSS Sodium 10 MG/ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0935-05001210935055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0935-1600121093516473 mL in 1 BOTTLE (0121-0935-16) 473 ml2021-08-160000-00-00NoNoCurrent
0121-0935-40001210935404 TRAY in 1 CASE (0121-0935-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0935-05) 4 tray2021-08-160000-00-00NoNoCurrent