Stool Softener

Product NDC: 63868-875
11-digit product format: 638680875
Labeler code: 63868
Product ID: 63868-875_7309543d-0d54-44ee-9635-302caa83fed5
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: 2018-12-31
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
Brand name suffix: Stimulant 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-05-11	DRUG FACTS
2023-01-30	DRUG FACTS
2020-11-30	DRUG FACTS
2020-09-27	DRUG FACTS
2020-09-25	DRUG FACTS
2020-07-22	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-875-01	Stool SoftenerStimulant laxative	100 in 1 BOTTLE, PLASTIC	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-875-01	EA - Each	63868-875	a374b41d-c498-4ab3-81fa-786104b65cf4	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-875	STOOL SOFTENER STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	4	Current NDC, Legacy NDC, 1 package rows	20240502_9467e1f7-19bb-4fb3-853b-75c4d28bb9a9.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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Preferred Pharmaceuticals Inc.	f8bba8cb-a111-4285-8bdb-2273a049c3bb	2026-07-08	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	Advanced Rx LLC	fc8cf24e-8ca1-b3fb-e053-6294a90a7a50	2026-07-06	Warnings	Exact identifier application number: M007
Curewell Docusate Sodium Liquid	DOCUSATE SODIUM.50MG/5ML	RMT HEALTH LLC	55903043-2a1d-0525-e063-6394a90ae182	2026-07-01	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES 8.6 MG TABLETS	Aarkish Pharmaceuticals NJ Inc.	564bc9a5-13b5-4cce-a349-6b2e122683ed	2026-07-01	Warnings	Exact identifier application number: M007
Senna-S	DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG	Aarkish Pharmaceuticals NJ Inc.	faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f	2026-07-01	Warnings	Exact identifier application number: M007
ENEMEEZ	DOCUSATE SODIUM	Quest Products, LLC	0b06445d-0839-497e-bdff-e0fe224a7738	2026-06-30	Warnings	Exact identifier application number: M007
ENEMEEZ Plus	DOCUSATE SODIUM AND BENZOCAINE	Quest Products, LLC	1670ca59-7275-4ac6-bef4-674a7b24c7b3	2026-06-30	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	CVS Pharmacy, Inc.	1183bcbc-51ec-e53a-e063-6394a90af0f2	2026-06-26	Warnings, Adverse reactions	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552d9018-cc7d-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552e16b9-f46a-7838-e063-6394a90ab8aa	2026-06-26	Warnings	Exact identifier application number: M007
Walgreens Gentle Laxative	BISACODYL SUPPOSITORY	Walgreens	20c43036-830b-0e1d-e063-6394a90adf5f	2026-06-25	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	American Health Packaging	be7cab51-ce7e-465d-95db-083e69288cfd	2026-06-25	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Vi-Jon, LLC	ba490c22-19f0-4887-9509-bd3d32e0f5b1	2026-06-24	Warnings, Adverse reactions	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	KROGER COMPANY	a1b0c638-6c34-1b72-e053-2995a90acc85	2026-06-24	Warnings	Exact identifier application number: M007
Womens Laxative	WOMENS LAXTIVE	Allegiant Health	549a11d1-a096-4c22-96b4-2d4f54f46022	2026-06-24	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Meijer Distribution Inc	f4259fda-19d4-087e-e053-2995a90a7081	2026-06-22	Warnings	Exact identifier application number: M007
STOOL SOFTENER	DOCUSATE SODIUM	Geri-Care Pharmaceuticals, Corp	3ec42148-6786-22f2-e054-00144ff8d46c	2026-06-18	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN SUPPOSITORY	Everpharm LLC	546347e5-841e-15ca-e063-6294a90a0c8b	2026-06-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN SUPPOSITORY	Everpharm LLC	5463f869-2b92-4551-e063-6394a90ad6f9	2026-06-16	Warnings	Exact identifier application number: M007
MINICA-S	GLYCERIN	Sato Pharmaceutical Co., Ltd.	687902eb-e702-4e87-a0ce-9add05e3cbc1	2026-06-16	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM
3FYP5M0IJX	SENNOSIDES		SENNOSIDES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	4
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	4
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-875-01	63868087501	100 TABLET in 1 BOTTLE, PLASTIC (63868-875-01)	100 tablet	2018-12-31	0000-00-00	No	No	Current