Home NDC 63868-946 Stool Softener Laxative
Product NDC 63868-946
11-digit product format 638680946
Labeler code 63868
Product ID 63868-946_866fb276-b4fd-4634-b66e-38a6b29bb980
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium and sennosides
Dosage form TABLET
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-31
Substance DOCUSATE SODIUM; SENNOSIDES
Active strength 50; 8.6 mg/1; mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 Stool Softener Laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 50 mg/1 SENNOSIDES 8.6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup 3FYP5M0IJX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998740 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 63868-946-01 Stool Softener Laxative 100 in 1 BOTTLE, PLASTIC TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-946 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 5 Current NDC, Legacy NDC, 1 package rows 20240502_72f8e8d7-ee38-4bd3-8711-f11fded0cede.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 41 · 817 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Gentle Laxative BISACODYL Meijer Distribution Inc. b49786a1-f0b9-45ae-b8f6-683489c54e76 2024-12-18 Warnings Exact identifier application number: M007 H E B Stool Softener laxative DOCUSATE SODIUM H E B 9d848fdd-3a2f-45c6-9ff3-17f1d74e0f4f 2024-12-18 Warnings Exact identifier application number: M007 Preferred Stool Softener laxative DOCUSATE SODIUM Reese Pharmaceutical Co 9135addd-4fc7-411b-b3c3-79e7e0e4cec8 2024-12-18 Warnings Exact identifier application number: M007 DOCUSATE SODIUM 100mg Two-Tone DOCUSATE SODIUM Discount Drug Mart, Inc 80092188-0517-4646-bd46-ab56c63bb354 2024-12-18 Warnings Exact identifier application number: M007 Winco Stool Softener DOCUSATE SODIUM WinCo Foods, LLC d74c54d6-7a75-4ca9-8425-7593b7841b0f 2024-12-18 Warnings Exact identifier application number: M007 Quality Choice Stool Softener laxative DOCUSATE SODIUM Chain Drug Marketing Association 7635b081-4350-45d0-b44e-82afccce2134 2024-12-18 Warnings Exact identifier application number: M007 Rite Aid Stool Softener DOCUSATE CALCIUM Rite Aid 281b2bc7-4980-4205-a33f-cb1974af8d06 2024-12-18 Warnings Exact identifier application number: M007 Topcare Stool Softener DOCUSATE SODIUM TOPCO ASSOCIATES LLC 93158bd3-c830-4b12-ab1c-133a4bdb9c78 2024-12-18 Warnings Exact identifier application number: M007 HEB Stool Softener DOCUSATE SODIUM H E B afc54b8e-03d9-418c-9322-97d68f929031 2024-12-18 Warnings Exact identifier application number: M007 Foster and Thrive Gentle Laxative BISACODYL Strategic Sourcing Services LLC d03c2c42-d9d9-4b4b-a6ae-31d99425a228 2024-12-18 Warnings Exact identifier application number: M007 EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE SENNOSIDES Haleon US Holdings LLC 59a26a7f-516f-4507-8dec-f40cf6cfaffc 2024-12-17 Warnings Exact identifier application number: M007 EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE SENNOSIDES Haleon US Holdings LLC fb170340-c996-46cf-b165-84e136ba4151 2024-12-17 Warnings Exact identifier application number: M007 Senna Syrup NATURAL VEGETABLE LAXATIVE Bryant Ranch Prepack 7d1f092e-0e5b-4fed-a095-64449751582d 2024-12-16 Warnings Exact identifier application number: M007 Drug Mart Vegetable Laxative plus Stool Softener DOCUSATE SODIUM, SENNOSIDES Discount Drug Mart, Inc 1b6d59e8-112f-447f-b6e9-526b7d3bd01e 2024-12-13 Warnings Exact identifier application number: M007 Drug Mart Stool Softener plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES Discount Drug Mart, Inc caf74258-922c-4b69-9bd6-57b3e918c7a6 2024-12-13 Warnings Exact identifier application number: M007 Docusate Sodium DOCUSATE SODIUM National Vitamin Company 0c66642c-82cb-42cd-82bb-5f95852cc5d1 2024-12-12 Warnings Exact identifier application number: M007 Foster and Thrive Fiber Laxative 147 CALCIUM POLYCARBOPHIL Strategic Sourcing Services LLC 88d341a6-28aa-4a20-bfed-1d5f3106c2ae 2024-12-12 Warnings Exact identifier application number: M007 Pedia-Lax SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC C.B. Fleet Company, Inc. f001a37d-8ed4-428b-af12-d6a83c22c127 2024-12-12 Warnings Exact identifier application number: M007 Careone Milk of magnesia Original Milk of Magnesia Original MAGNESIUM HYDROXIDE Retail Business Services, LLC. 13ffb00b-7c6f-47aa-bc82-2402d121a758 2024-12-11 Warnings Exact identifier application number: M007 CareOne Milk of Magnesia Cherry MAGNESIUM HYDROXIDE Retail Business Services, LLC. 1822f90d-f693-48d7-b338-a3f2ddfac4df 2024-12-11 Warnings Exact identifier application number: M007
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-946-01 63868094601 100 TABLET in 1 BOTTLE, PLASTIC (63868-946-01) 100 tablet 2021-03-31 0000-00-00 No No Current