FDA.reportPublic FDA data

Docusate Sodium

Product NDC
53345-035
11-digit product format
533450035
Labeler code
53345
Product ID
53345-035_27680f73-0432-5efe-e063-6394a90ae8b7
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-10
Substance
DOCUSATE SODIUM
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 SODIUM250 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
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-035-01Docusate Sodium7000 in 1 BAGCAPSULE, LIQUID FILLED70003
53345-035-01Docusate Sodium1 in 1 BOXCAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-035DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD]3Current NDC, Legacy NDC, 2 package rows20241122_33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0.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 21 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fiber Therapy Sugar FreePSYLLIUM HUSKPUBLIX SUPER MARKETS, INCed3dc80a-a243-4013-9886-b148e3e3b6622025-10-28WarningsExact identifier
application number: M007
Childrens Oral Saline LaxativeMAGNESIUM HYDROXIDEWAL-MART STORES,INC.,a2eb50ab-851a-4abb-a12f-6d9d8b0cb6bc2025-10-27WarningsExact identifier
application number: M007
equate Fiber TherapyMETHYLCELLULOSEWal-Mart Stores,Inc.,7acc30b4-e946-42cd-8eec-cf15159d478d2025-10-27WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97aa5b-62e2-0664-e053-2a91aa0ac3412025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d03ce42-e671-6d76-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCVS Pharmacyc56e010a-7503-3e1c-e053-2a95a90a2b852025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLMajor Pharmaceuticalsc194c40c-c732-2f03-e053-2a95a90a7a402025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLPharmacy Value Alliance LLC8a6d6729-f6eb-4f68-e053-2a95a90a5c9e2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCardinal Healthc2b33e78-6ab7-1785-e053-2995a90a9c4f2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN33251cb7-b7b1-4f6c-9e10-4fa64cbf03a03
1245468docusate sodium 250 MG Oral CapsuleSCD33251cb7-b7b1-4f6c-9e10-4fa64cbf03a03
1245468DOSS Sodium 250 MG Oral CapsuleSY33251cb7-b7b1-4f6c-9e10-4fa64cbf03a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-035-01533450035011 BAG in 1 BOX (53345-035-01) / 7000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2016-02-100000-00-00NoNoCurrent