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

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui998740

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

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