Stool Softener

Product NDC: 68071-5297
11-digit product format: 680715297
Labeler code: 68071
Product ID: 68071-5297_53728778-9acd-ab94-e063-6294a90a47ec
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-01
Substance: DOCUSATE SODIUM
Active strength: 250 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	250 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
1245468	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
53727f3a-914c-0e2c-e063-6394a90a3886	Available on FDA.report

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 28 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	EXTRA STRENGTH PAIN RELIEF	NuCare Pharmaceuticals,Inc.	a32f346e-71d0-cc11-e053-2a95a90ae88c	2024-12-31	Warnings	Exact identifier application number: M007
Laxacin	DOCUSATE SODIUM AND SENNOSIDES	Advanced Rx Pharmacy of Tennessee, LLC	fe7d4d75-0f8a-1e7d-e053-6394a90afb4d	2024-12-31	Warnings	Exact identifier application number: M007
NATUREPLEX Enema	(SALINE)	Natureplex, LLC	0bd6d0a8-33e5-40be-a6c6-33fea92b11dd	2024-12-31	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CVS Pharmacy, Inc.	fb7f9b67-ff0e-3af4-e053-6294a90ac539	2024-12-30	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CVS Pharmacy, Inc.	fb808dc5-bf80-836c-e053-6294a90a80aa	2024-12-30	Warnings	Exact identifier application number: M007
Magnesium Citrate	CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CVS Pharmacy, Inc.	fb80ffce-a7b6-7f19-e053-6294a90a5c6b	2024-12-30	Warnings	Exact identifier application number: M007
Foster and Thrive Castor Oil	CASTOR OIL	Strategic Sourcing Services, LLC	004d1dc2-47c1-84d1-e063-6394a90a2471	2024-12-30	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	A-S Medication Solutions	946abcdb-96bd-43e6-992a-bb97679c00f0	2024-12-30	Warnings	Exact identifier application number: M007
HEB Maximum strength Laxative pills	SENNOSIDES	H E B	86e5dff5-91e6-47a5-8f3c-b1e86adfc1f4	2024-12-26	Warnings	Exact identifier application number: M007
Equaline Regular Strength Chocolated Stimulant Laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	e9200d63-a0d1-4f68-bb5e-7507c46cf800	2024-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effad954-b70d-d8e6-e053-2a95a90acaf7	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effad365-d76e-71af-e053-2995a90aa020	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	WALGREEN COMPANY	effaeff6-c48b-1558-e053-2995a90ab52f	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	STRATEGIC SOURCING SERVICES	f9e1291a-f64d-2431-e053-6394a90a35f1	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	AMERISOURCE BERGEN	f384094e-c4d2-3882-e053-2995a90a7794	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	AMERISOURCE BERGEN	f3847b0f-802d-73d7-e053-2a95a90a5bbe	2024-12-23	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	STRATEGIC SOURCING SERVICES	f9e1291a-f650-2431-e053-6394a90a35f1	2024-12-23	Warnings	Exact identifier application number: M007
Leader Regular Strength Chocolate Laxative sennosides	SENNOSIDES	CARDINAL HEALTH	1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e	2024-12-23	Warnings	Exact identifier application number: M007
Chocolated Laxative	SENNOSIDES STIMULANT LAXATIVE	Walgreens	c8ea170b-57b5-4643-ba88-4cf2ae1bf6a0	2024-12-23	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Meijer, Inc.	b09a234e-962d-49fc-a72e-898547b2f099	2024-12-23	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-5297-6	68071529706	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-5297-6)	2026-06-04	No	No	Current