Home NDC 68788-8919 Stool Softener
Product NDC 68788-8919
11-digit product format 687888919
Labeler code 68788
Product ID 68788-8919_1ca4d341-98ff-45a0-8d2e-65b39ed50253
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application 334
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-09-18
Substance DOCUSATE SODIUM
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 68788-8919-1 excluded package package 68788-8919-6 excluded package package 68788-8919-3
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Stool Softener
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115005 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8919-1 Stool Softener 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 11 68788-8919-3 Stool Softener 30 in 1 BOTTLE CAPSULE, LIQUID FILLED 30 11 68788-8919-6 Stool Softener 60 in 1 BOTTLE CAPSULE, LIQUID FILLED 60 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 DOCUSATE ACTIVE MOIETY M7P27195AG STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.] 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-8919-1 68788891901 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-8919-1) 2015-09-18 0000-00-00 No No Current 68788-8919-3 68788891903 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-8919-3) 2015-09-18 0000-00-00 No No Current 68788-8919-6 68788891906 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-8919-6) 2015-09-18 0000-00-00 No No Current