Home NDC 63868-137 Stool Softener plus Laxative
Product NDC 63868-137
11-digit product format 638680137
Labeler code 63868
Product ID 63868-137_5202a0fe-e095-4377-882e-3f61527200f3
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM, SENNOSIDES
Dosage form TABLET
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-11-30
Marketing end 0000-00-00
Substance DOCUSATE SODIUM; SENNOSIDES
Active strength 50 mg/1; mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 63868-137 I Inactivated by FDA 2026-07-31 excluded package package 63868-137 63868-137-60 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Docusate Sodium DOCUSATE SODIUM Preferred Pharmaceuticals Inc. 4e30b602-1ac2-48e6-a8b0-fd1dc97a3f48 2026-04-08 Warnings Exact identifier Stimulant Laxative Plus Stool Softener DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG Preferred Pharmaceuticals, Inc. b25b8a28-5e00-4a20-9ca3-7ed494fc4540 2025-09-24 Warnings Exact identifier STIMULANT LAXATIVE BISACODYL TIME CAP LABORATORIES, INC. e0a9f8d9-660b-431c-8043-6d8ec81f98e5 2019-09-27 Warnings Exact identifier WOMENS GENTLE LAXATIVE BISACODYL TARGET CORPORATION 7cabd434-f48f-a16a-e053-2991aa0a2bb3 2019-04-16 Warnings Exact identifier STOOL SOFTENING SENNA LAXATIVE SENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MG TARGET CORPORATION 7c74bd91-6687-2b89-e053-2a91aa0ad6b8 2019-02-28 Warnings Exact identifier FREDS SALINE TWIN PACK LAXATIVE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM FRED'S 7d15057f-eb3b-477f-ab14-68c3c38ea910 2018-12-26 Warnings Exact identifier Marcs Twin Pack SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM Marc Glassman Inc. 66348ee5-803a-4b78-94dd-55bc9d3543c3 2018-07-10 Warnings Exact identifier QUALITY CHOICE SINGLE SALINE LAXATIVE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM Alcyon Health, LLC. eb499c7f-9c7b-4097-83a3-82aabffd6beb 2017-07-12 Warnings Exact identifier Pro-Enema Single Saline Laxative SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM Propharma Medical Supplies e53c5eda-21da-4aed-a592-315100167cc2 2017-06-08 Warnings Exact identifier Saline Laxative Cherry Laxative SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM Dolgencorp Inc. ca3c00d9-4301-4de8-94f5-34f1bcc761ab 2017-04-13 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use • if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-137-60 Stool Softener plus Laxative 1 in 1 BOX TABLET 1 4 63868-137-60 Stool Softener plus Laxative 60 in 1 BOTTLE TABLET 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-137 STOOL SOFTENER PLUS LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 4 Legacy NDC, 2 package rows 20221109_6dbf9db3-7489-458b-ba20-69dd38a0e40c.zip
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 63868-137-60 63868013760 1 BOTTLE in 1 BOX (63868-137-60) > 60 TABLET in 1 BOTTLE 1 bottle 2015-11-30 0000-00-00 No No Current