Docusate Sodium

Product NDC: 76420-225
11-digit product format: 764200225
Labeler code: 76420
Product ID: 76420-225_07cec8ef-ecca-ac49-e063-6294a90a6083
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-01-01
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: Docusate Sodium
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
30fc8c07-c26b-4bcc-a727-6e193f5727fd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-225-30	Docusate Sodium	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	2
76420-225-60	Docusate Sodium	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60	2
76420-225-90	Docusate Sodium	90 in 1 BOTTLE	CAPSULE, LIQUID FILLED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-225-30	EA - Each	76420-225	8fa84f45-d979-4dec-8243-a7aca0445518	1	2022-09-12
76420-225-60	EA - Each	76420-225	ed6e1a5d-d719-44ca-9328-f67821dc73cd	1	2022-09-12
76420-225-90	EA - Each	76420-225	6c2a0546-21b5-466c-840d-d621cc485629	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-225	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20231016_30fc8c07-c26b-4bcc-a727-6e193f5727fd.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 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-225-30	76420022530	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (76420-225-30)	2022-07-07	0000-00-00	No	No	Current
76420-225-60	76420022560	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (76420-225-60)	2022-07-07	0000-00-00	No	No	Current
76420-225-90	76420022590	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (76420-225-90)	2022-07-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docusate Sodium - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-16	HUMAN OTC DRUG LABEL	2