Home NDC 67618-201 COLACE EXTRA STRENGTH
Product NDC 67618-201
11-digit product format 676180201
Labeler code 67618
Product ID 67618-201_cb4d4f5a-9ae0-4cab-9806-017c6088f77f
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Atlantis Consumer Healthcare Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-05
Substance DOCUSATE SODIUM
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 COLACE EXTRA STRENGTH
Brand name suffix STOOL SOFTNER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 250 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1245468 Internal RxNorm lookup 2692740 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67618-201-12 COLACE EXTRA STRENGTHSTOOL SOFTNER 2 in 1 PACKAGE CAPSULE, LIQUID FILLED 2 3 67618-201-12 COLACE EXTRA STRENGTHSTOOL SOFTNER 60 in 1 BOTTLE CAPSULE, LIQUID FILLED 60 3 67618-201-60 COLACE EXTRA STRENGTHSTOOL SOFTNER 60 in 1 BOTTLE CAPSULE, LIQUID FILLED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67618-201 COLACE EXTRA STRENGTH STOOL SOFTNER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [ATLANTIS CONSUMER HEALTHCARE INC.] 3 Current NDC, 3 package rows 20250507_34e06b05-64a5-4b3e-af38-cdcd7c1d521b.zip
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 30 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67618-201-12 67618020112 2 BOTTLE in 1 PACKAGE (67618-201-12) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE 2 bottle 2025-07-01 No No Current 67618-201-60 67618020160 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (67618-201-60) 2024-08-05 No No Current