FDA.reportPublic FDA data

Laxative and Stool Softener

Product NDC
49035-360
11-digit product format
490350360
Labeler code
49035
Product ID
49035-360_f186489d-cd91-4806-ada4-1e16991d522f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM, SENNOSIDES
Dosage form
TABLET
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative and 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
5be43e46-e49b-49eb-a95f-7c4577032f90Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-360-30Laxative and Stool Softener1 in 1 BOXTABLET16
49035-360-30Laxative and Stool Softener30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-360-30EA - Each49035-360164a762f-7616-4b0e-b1e7-9b96e2991f3312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-360LAXATIVE AND STOOL SOFTENER (DOCUSATE SODIUM, SENNOSIDES) TABLET [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]6Current NDC, Legacy NDC, 2 package rows20240810_5be43e46-e49b-49eb-a95f-7c4577032f90.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
Laxative and Stool SoftenerDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)5be43e46-e49b-49eb-a95f-7c4577032f902026-07-13WarningsExact identifier
ndc (product): 49035-360

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN5be43e46-e49b-49eb-a95f-7c4577032f906
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD5be43e46-e49b-49eb-a95f-7c4577032f906
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY5be43e46-e49b-49eb-a95f-7c4577032f906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-360-30490350360301 BOTTLE, PLASTIC in 1 BOX (49035-360-30) / 30 TABLET in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent