Home NDC 53345-015 DOCUSATE SODIUM 50 MG
Product NDC 53345-015
11-digit product format 533450015
Labeler code 53345
Product ID 53345-015_27c70a38-225f-2753-e063-6394a90a9560
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-11-12
Substance DOCUSATE SODIUM
Active strength 50 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 DOCUSATE SODIUM 50 MG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 50 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 1247759 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 53345-015-01 DOCUSATE SODIUM 50 MG 20000 in 1 BAG CAPSULE, LIQUID FILLED 20000 3 53345-015-01 DOCUSATE SODIUM 50 MG 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 DOCUSATE ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-015 DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 3 Current NDC, Legacy NDC, 2 package rows 20241127_af7533e6-8b06-48a4-940e-7ecb57b24b59.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 31 of 42 · 833 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 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 milk of magnesia MAGNESIUM HYDROXIDE CVS Pharmacy b3a36251-edd6-4201-8da1-85d7a6ede173 2024-12-05 Warnings Exact identifier application number: M007 CITRUCEL METHYLCELLULOSE Haleon US Holdings LLC d27f6742-2dcc-451e-b803-6ffe183038ec 2024-12-05 Warnings Exact identifier application number: M007 Laxacin DOCUSATE SODIUM AND SENNOSIDES Alexso, Inc 0df9abaf-3997-4dde-8003-ae3d8d07cf39 2024-12-04 Warnings Exact identifier application number: M007 NuValu Epsom Salt MAGNESIUM SULFATE (HEPTAHYDRATE) J C SALES 9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd 2024-12-04 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 53345-015-01 53345001501 1 BAG in 1 BOX (53345-015-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2013-11-12 0000-00-00 No No Current