Stool Softener Laxative

Product NDC: 70000-0091
11-digit product format: 700000091
Labeler code: 70000
Product ID: 70000-0091_91e9523b-ba92-4e22-b50c-1f798ce0ba96
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-01-31
Substance: DOCUSATE SODIUM
Active strength: 100 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 Laxative
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	100 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
1115005	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
da5ccd75-8a2f-4f90-ae8a-97d81b8579d2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70000-0091-1	Stool Softener Laxative	100 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	100	7
70000-0091-2	Stool Softener Laxative	250 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	250	7
70000-0091-3	Stool Softener Laxative	750 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	750	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0091-1	EA - Each	70000-0091	6dad384a-e8d6-414e-9676-91e6b32878c9	1	2021-08-05
70000-0091-2	EA - Each	70000-0091	9acee37a-b414-496f-8fb2-f534d08dc919	1	2021-08-05
70000-0091-3	EA - Each	70000-0091	a8b21a91-f5e2-41bf-8c55-3a7afd31db22	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0091	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]	5	Current NDC, Legacy NDC, 3 package rows	20240111_da5ccd75-8a2f-4f90-ae8a-97d81b8579d2.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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750e0355-369e-b679-e053-2a91aa0a66ca	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750efd58-5845-fbc4-e053-2a91aa0a86d1	2023-11-01	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	ba4a29b3-2ddc-b906-e053-2995a90a2ab7	2023-11-01	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	92879e62-f60a-4ab4-9532-610cdd2628ee	2023-11-01	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	5999904a-6ac8-4d9e-951c-6e64e8cd93eb	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e98f9d9-679c-63a2-e053-2991aa0a4b8d	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e957b01-4f44-0a2a-e053-2991aa0a37a0	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e993b13-8dc8-6653-e053-2a91aa0a4c2a	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	CVS	3c8e4144-6702-2678-e054-00144ff88e88	2023-10-31	Warnings	Exact identifier application number: M007
Fiber Laxative	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	9d22c208-d089-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	a0e6ab9b-fd31-45fd-93d5-b51d705c180a	2023-10-27	Warnings	Exact identifier application number: M007
Sennosides Natural Laxative	SENNOSIDES	Magno-Humphries, Inc.	9d22bedb-9fca-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	9d22d642-8aed-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM, SENNOSIDES	Magno-Humphries, Inc.	9deaf264-6af0-40ba-e053-2a95a90ada0e	2023-10-27	Warnings	Exact identifier application number: M007
FLEET	MINERAL OIL	C.B. Fleet Company, Inc.	2528cb5e-437e-41f0-9c34-e9ce57404d8b	2023-10-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Major Pharmaceuticals	088e5543-c947-af78-e063-6294a90a8bc4	2023-10-25	Warnings	Exact identifier application number: M007
DOK	DOCUSATE SODIUM	MAJOR PHARMACEUTICALS	7a92070d-98cc-662f-e053-2991aa0aa1b2	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	KROGER COMPANY	a1afaa71-7e8c-5a49-e053-2a95a90a4db0	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Asclemed USA, Inc.	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2023-10-16	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	da5ccd75-8a2f-4f90-ae8a-97d81b8579d2	7
1115005	docusate sodium 100 MG Oral Capsule	SCD	da5ccd75-8a2f-4f90-ae8a-97d81b8579d2	7
1115005	DOSS Sodium 100 MG Oral Capsule	SY	da5ccd75-8a2f-4f90-ae8a-97d81b8579d2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0091-1	70000009101	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-1)	2021-01-31	0000-00-00	No	No	Current
70000-0091-2	70000009102	250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-2)	2021-01-31	0000-00-00	No	No	Current
70000-0091-3	70000009103	750 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-3)	2021-01-31	0000-00-00	No	No	Current