Stool Softener Laxative

Product NDC
63868-638
11-digit product format
638680638
Labeler code
63868
Product ID
63868-638_43425455-08ef-401f-a486-eb9f5da92148
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-30
Substance
DOCUSATE SODIUM
Active strength
100 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 SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-638-252022-12-14C16284748780-1d6a99b39-4c94-a426-e053-dadaa90af4c2Drug Facts
63868-638-252022-01-28C16284748780-1d6a99b39-4c94-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-638-25Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-638STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 1 package rows20240423_96c7f8bc-be95-40d1-9977-44b7cc6582df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN96c7f8bc-be95-40d1-9977-44b7cc6582df3
1115005docusate sodium 100 MG Oral CapsuleSCD96c7f8bc-be95-40d1-9977-44b7cc6582df3
1115005DOSS Sodium 100 MG Oral CapsuleSY96c7f8bc-be95-40d1-9977-44b7cc6582df3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-638-2563868063825250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (63868-638-25) 2021-12-300000-00-00NoNoCurrent