FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
21130-041
11-digit product format
211300041
Labeler code
21130
Product ID
21130-041_785f0ec2-8f6f-4d90-b059-1982cdc22377
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
2021-01-31
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-041-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2004
21130-041-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604
21130-041-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-041STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAFEWAY, INC.]3Current NDC, Legacy NDC, 3 package rows20240404_12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c4
1115005docusate sodium 100 MG Oral CapsuleSCD12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c4
1115005DOSS Sodium 100 MG Oral CapsuleSY12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-041-2021130004120200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (21130-041-20) 2021-01-310000-00-00NoNoCurrent
21130-041-60211300041601 BOTTLE, PLASTIC in 1 BOX (21130-041-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-31NoNoHistorical