FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
63868-884
11-digit product format
638680884
Labeler code
63868
Product ID
63868-884_d1f85142-3a8f-495d-b1fc-2467fd512710
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-30
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

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 Laxative
Listing expiration
2026-12-31

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
19e10544-81f4-4c2d-8a63-238c562c2f5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-884-012023-05-11C16284748780-1f386c64a-0335-0266-e053-dadaa90a7c1aDRUG FACTS
63868-884-012023-01-30C16284748780-1f386c64a-0335-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-884-01Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-884STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 1 package rows20240906_19e10544-81f4-4c2d-8a63-238c562c2f5c.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 Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)19e10544-81f4-4c2d-8a63-238c562c2f5c2024-09-04WarningsExact identifier
ndc (product): 63868-884

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN19e10544-81f4-4c2d-8a63-238c562c2f5c6
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD19e10544-81f4-4c2d-8a63-238c562c2f5c6
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY19e10544-81f4-4c2d-8a63-238c562c2f5c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-884-0163868088401100 TABLET in 1 BOTTLE, PLASTIC (63868-884-01) 100 tablet2020-06-300000-00-00NoNoCurrent