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 33 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premier Value Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	2d580965-2bef-46ee-8532-fbe34330a4b4	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy	METHYLCELLULOSE	PHARMACY VALUE ALLIANCE, LLC	b875d5f8-02f3-4474-9fda-83091bc7de04	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Original Coarse	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	8c85a13d-ae99-4599-9a28-c3965caa6376	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value	CALCIUM POLYCARBOPHIL	PHARMACY VALUE ALLIANCE, LLC	4d766548-00d0-41bd-bb58-b69e037c77e2	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber	PSYLLIUM HUSK	Chain Drug Consortium, LLC	c507fe4a-1f8e-4780-a2f5-9da6e5922bef	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	85651bd7-e959-4455-a5ed-bd0223ce0563	2024-10-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c61c71-9a23-4bd3-e053-2a95a90ad460	2024-10-26	Warnings	Exact identifier application number: M007
Pedia-Lax	GLYCERIN	C.B. Fleet Company, Inc.	ae367381-7146-4307-823d-2bb44c1d4200	2024-10-25	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	f7309f4a-f1f5-420e-bfc7-fb4495a5afba	2024-10-24	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	2540ae39-2218-0f6a-e063-6294a90a5efc	2024-10-24	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	Sam's West Inc	b0e99ebb-41fc-459f-86d2-f0e3527f97b0	2024-10-24	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	A-S Medication Solutions	ef05ad45-7082-43e6-9533-a79c5aa0f373	2024-10-22	Warnings	Exact identifier application number: M007
Bliss GVS Children	GLYCERIN	Bliss GVS Pharma Limited	03237ed2-265f-4acd-b504-d82b9263287c	2024-10-17	Warnings	Exact identifier application number: M007
NATURAL Epsom Salt	MAGNESIUM SULFATE	Universal Distribution Center LLC	b2682e51-ffa4-4556-b2a6-b0dbd543fd4f	2024-10-16	Warnings	Exact identifier application number: M007
Bliss GVS	GLYCERIN	Bliss GVS Pharma Limited	1a3982a1-9ce9-4a1a-ba73-ebe2d8647109	2024-10-10	Warnings	Exact identifier application number: M007
Bisacodyl	BISACODYL	Padagis US LLC	7eada0fc-5f83-43da-a56f-b0f537298208	2024-10-10	Warnings	Exact identifier application number: M007
exchange select stool softener	DOCUSATE SODIUM	Army & Air Force Exchange Service	14985848-d791-42b9-ad7e-810a85bb1ee1	2024-10-07	Warnings	Exact identifier application number: M007
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2024-10-01	Warnings	Exact identifier application number: M007
Pedia-Lax	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	0e908bea-ebab-44e7-919c-90002e6f5d42	2024-10-01	Warnings	Exact identifier application number: M007
Natural Vegetable Laxative and Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c562e1-4080-44cb-e053-2a95a90a4222	2024-09-25	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