Home NDC 57896-421 STOOL SOFTENER
Product NDC 57896-421
11-digit product format 578960421
Labeler code 57896
Product ID 57896-421_548956c0-c6c7-be65-e063-6294a90a44fe
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium
Dosage form TABLET
Route ORAL
Labeler Geri-Care Pharmaceuticals, Corp
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-09-01
Substance DOCUSATE SODIUM
Active strength 100 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
Listing expiration 2027-12-31 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 1099279 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 57896-421-01 STOOL SOFTENER 100 in 1 BOTTLE TABLET 100 5 57896-421-10 STOOL SOFTENER 1000 in 1 BOTTLE TABLET 1000 5 57896-421-20 STOOL SOFTENER 200 in 1 BOTTLE TABLET 200 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-421 STOOL SOFTENER (DOCUSATE SODIUM) TABLET [GERI-CARE PHARMACEUTICALS, CORP] 5 Current NDC, Legacy NDC, 3 package rows 20241218_3ec42148-6786-22f2-e054-00144ff8d46c.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 32 of 43 · 858 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Epsom Salts MAGNESIUM SULFATE Jell Pharmaceuticals Pvt. Ltd. 8d4443ec-fc8b-0119-e053-2a95a90a68f0 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 MILK OF MAGNESIA MINT MAGNESIUM HYDROXIDE GOOD SENSE a951b6d0-9182-e1bc-e053-2a95a90a12b1 2024-12-09 Warnings Exact identifier application number: M007 Sennosides SENNOSIDES Major Pharmaceuticals df3b431b-a1ad-91dd-e053-2995a90aa02f 2024-12-06 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 57896-421-01 57896042101 100 TABLET in 1 BOTTLE (57896-421-01) 100 tablet 2015-09-01 0000-00-00 No No Current 57896-421-10 57896042110 1000 TABLET in 1 BOTTLE (57896-421-10) 1000 tablet 2015-09-01 0000-00-00 No No Current 57896-421-20 57896042120 200 TABLET in 1 BOTTLE (57896-421-20) 200 tablet 2019-05-01 0000-00-00 No No Current