FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
70677-0034
Requested package NDC
70677-0034-1
11-digit product format
706770034
Labeler code
70677
Product ID
70677-0034_3bc6b532-7719-4bd0-8bba-f7d7e2c73963
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-08-31
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage70677-003470677-0034-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0034-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1006
70677-0034-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0034-1EA - Each70677-00343106064a-80ac-4ea4-9e0d-74f545113ab812018-05-09
70677-0034-2EA - Each70677-003433b6bfc4-68f7-4fa1-88fe-79cc8cc969a212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0034STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]5Legacy NDC, 2 package rows20240601_cb2df470-aef6-4c75-9596-6e50694d881e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNcb2df470-aef6-4c75-9596-6e50694d881e6
1115005docusate sodium 100 MG Oral CapsuleSCDcb2df470-aef6-4c75-9596-6e50694d881e6
1115005DOSS Sodium 100 MG Oral CapsuleSYcb2df470-aef6-4c75-9596-6e50694d881e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70677-0034-170677003401100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70677-0034-1) 2017-08-310000-00-00NoNoCurrent