FDA.reportPublic FDA data

Stool Softener

Product NDC
69618-086
11-digit product format
696180086
Labeler code
69618
Product ID
69618-086_44fae16b-d2fe-bf32-e063-6394a90a74b1
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-086-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-086-01EA - Each69618-086ed57a7b6-24b7-4ac3-bbb3-0671c65b527d12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN44fae161-3fc8-64c4-e063-6294a90a1d261
1115005docusate sodium 100 MG Oral CapsuleSCD44fae161-3fc8-64c4-e063-6294a90a1d261
1115005DOSS Sodium 100 MG Oral CapsuleSY44fae161-3fc8-64c4-e063-6294a90a1d261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69618-086-0169618008601100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69618-086-01) 2025-09-01NoNoHistorical