FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
21130-853
11-digit product format
211300853
Labeler code
21130
Product ID
21130-853_6d85ce2d-8c57-41bf-8217-eb10de22dca5
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Safeway, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-29
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-853-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2004
21130-853-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604
21130-853-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-853STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAFEWAY, INC.]3Current NDC, Legacy NDC, 3 package rows20240404_f178b31d-4843-4b91-a0d5-ab5ade835dc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNf178b31d-4843-4b91-a0d5-ab5ade835dc24
1115005docusate sodium 100 MG Oral CapsuleSCDf178b31d-4843-4b91-a0d5-ab5ade835dc24
1115005DOSS Sodium 100 MG Oral CapsuleSYf178b31d-4843-4b91-a0d5-ab5ade835dc24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-853-2021130085320200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (21130-853-20) 2021-01-290000-00-00NoNoCurrent
21130-853-60211300853601 BOTTLE, PLASTIC in 1 BOX (21130-853-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-29NoNoHistorical