FDA.reportPublic FDA data

Stool Softener

Product NDC
70677-1094
Requested package NDC
70677-1094-1
11-digit product format
706771094
Labeler code
70677
Product ID
70677-1094_37002ed2-5b89-4dd6-9e54-99734820aa31
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-31
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Stool Softener
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b23e53d4-fd7d-452d-a851-35a143b6dcb4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1094-1Stool Softener100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1094-1EA - Each70677-10946119c3c7-d3f4-4c0b-b0b0-50c61e23384212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1094STOOL SOFTENER (DOCUSATE SODIUM AND SENNOSIDES) TABLET [STRATEGIC SOURCING SERVICES LLC]4Current NDC, 1 package rows20240709_b23e53d4-fd7d-452d-a851-35a143b6dcb4.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services LLCb23e53d4-fd7d-452d-a851-35a143b6dcb42024-07-08WarningsExact identifier
ndc (package): 70677-1094-1
ndc (product): 70677-1094
ndc11 (package): 70677109401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNb23e53d4-fd7d-452d-a851-35a143b6dcb44
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDb23e53d4-fd7d-452d-a851-35a143b6dcb44
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYb23e53d4-fd7d-452d-a851-35a143b6dcb44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1094-170677109401100 TABLET in 1 BOTTLE, PLASTIC (70677-1094-1) 100 tablet2023-03-31NoNoCurrent