DOCUSATE SODIUM

Product NDC: 53345-008
11-digit product format: 533450008
Labeler code: 53345
Product ID: 53345-008_2766d54c-3cf9-0b55-e063-6394a90a886d
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-04-15
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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: 2026-12-31

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
b10fdf50-289e-41f3-9b83-a4e4dd892f88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53345-008-01	DOCUSATE SODIUM	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	4
53345-008-01	DOCUSATE SODIUM	20000 in 1 BAG	CAPSULE, LIQUID FILLED	20000	4
53345-008-02	DOCUSATE SODIUM	15000 in 1 BAG	CAPSULE, LIQUID FILLED	15000	4
53345-008-02	DOCUSATE SODIUM	1 in 1 BOX	CAPSULE, LIQUID FILLED	1	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
DOCUSATE	ACTIVE MOIETY	M7P27195AG	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53345-008	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	4	Current NDC, Legacy NDC, 4 package rows	20241123_b10fdf50-289e-41f3-9b83-a4e4dd892f88.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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	b1d903a5-1d5f-44d4-9939-a4b86e5a620d	2024-05-23	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8	2024-05-23	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	MEIJER, INC.	11fe5bd0-585a-ad8a-e063-6294a90a3ae8	2024-05-22	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Sam's West, Inc	b14d2495-1092-4063-869f-73a7e8c28708	2024-05-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d	2024-05-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	c0898583-4bbb-41d5-9e84-00cca823024f	2024-05-15	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9c986ca8-d540-49c1-b092-94c1bf837c07	2024-05-09	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	381f4179-0c3b-41f8-927c-c88534ebe06d	2024-05-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	ed20d198-e935-200e-e053-2a95a90a309b	2024-05-02	Warnings	Exact identifier application number: M007
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Major Pharmaceuticals	1768b470-2808-fa46-e063-6394a90ac8d9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Stimulant laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	72f8e8d7-ee38-4bd3-8711-f11fded0cede	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	c1e9863a-c229-4694-b450-6b0e0ad37503	2024-04-30	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	96c7f8bc-be95-40d1-9977-44b7cc6582df	2024-04-22	Warnings	Exact identifier application number: M007
Pedia-Lax	MAGNESIUM HYDROXIDE	C.B. Fleet Company, Inc.	975f24d8-218c-40f4-84a5-558acf34329d	2024-04-11	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	H E B	2f9e2723-53a7-47a8-8c41-87bffc4e50dd	2024-04-09	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	H E B	d047e4e9-b8ac-498e-9fde-8af5d415edaa	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	5b8bcc6c-de03-4d73-a76f-6f4c371cf250	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	H E B	1dd2be7e-bdca-4e43-b853-3ed10b636632	2024-04-08	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	1f11cf85-b094-4ca4-8b48-2d3a9093304b	2024-04-04	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	97561cd4-63d9-44c2-a3a3-ec668a09a4ed	9
1115005	docusate sodium 100 MG Oral Capsule	SCD	97561cd4-63d9-44c2-a3a3-ec668a09a4ed	9
1115005	DOSS Sodium 100 MG Oral Capsule	SY	97561cd4-63d9-44c2-a3a3-ec668a09a4ed	9
1115005	docusate sodium 100 MG Oral Capsule	PSN	056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a138	5
1115005	docusate sodium 100 MG Oral Capsule	SCD	056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a138	5
1115005	DOSS Sodium 100 MG Oral Capsule	SY	056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a138	5
1115005	docusate sodium 100 MG Oral Capsule	PSN	816c82f8-0fa5-4b22-a226-e8f22f3eaa1d	4
1115005	docusate sodium 100 MG Oral Capsule	PSN	b10fdf50-289e-41f3-9b83-a4e4dd892f88	4
1115005	docusate sodium 100 MG Oral Capsule	SCD	816c82f8-0fa5-4b22-a226-e8f22f3eaa1d	4
1115005	docusate sodium 100 MG Oral Capsule	SCD	b10fdf50-289e-41f3-9b83-a4e4dd892f88	4
1115005	DOSS Sodium 100 MG Oral Capsule	SY	816c82f8-0fa5-4b22-a226-e8f22f3eaa1d	4
1115005	DOSS Sodium 100 MG Oral Capsule	SY	b10fdf50-289e-41f3-9b83-a4e4dd892f88	4
1115005	docusate sodium 100 MG Oral Capsule	PSN	88cc2575-27a1-4514-bc41-bd1eac283814	3
1115005	docusate sodium 100 MG Oral Capsule	PSN	8066a52d-e683-47c1-905c-290d2d427acf	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	88cc2575-27a1-4514-bc41-bd1eac283814	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	8066a52d-e683-47c1-905c-290d2d427acf	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	88cc2575-27a1-4514-bc41-bd1eac283814	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	8066a52d-e683-47c1-905c-290d2d427acf	3
1115005	docusate sodium 100 MG Oral Capsule	PSN	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2
1115005	docusate sodium 100 MG Oral Capsule	PSN	f4671579-aed0-4f93-ab83-248e0d72b5b0	2
1115005	docusate sodium 100 MG Oral Capsule	PSN	8b033d56-b95b-4905-9f33-cf2fbd61ce35	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	f4671579-aed0-4f93-ab83-248e0d72b5b0	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	8b033d56-b95b-4905-9f33-cf2fbd61ce35	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	f4671579-aed0-4f93-ab83-248e0d72b5b0	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	8b033d56-b95b-4905-9f33-cf2fbd61ce35	2
1115005	docusate sodium 100 MG Oral Capsule	PSN	946abcdb-96bd-43e6-992a-bb97679c00f0	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	946abcdb-96bd-43e6-992a-bb97679c00f0	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	946abcdb-96bd-43e6-992a-bb97679c00f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53345-008-01	53345000801	1 BAG in 1 BOX (53345-008-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2013-04-15	0000-00-00	No	No	Current
53345-008-02	53345000802	1 BAG in 1 BOX (53345-008-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2013-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2026-08-10	HUMAN OTC DRUG LABEL	3
DRUG FACTS	CVS PHARMACY, INC	2026-05-20	HUMAN OTC DRUG LABEL	5
DRUG FACTS	Major Pharmaceuticals	2025-10-31	HUMAN OTC DRUG LABEL	9
DRUG FACTS	Good Sense (Geiss, Destin & Dunn, Inc.)	2025-08-12	HUMAN OTC DRUG LABEL	3
Drug Facts	Walgreens	2025-05-23	HUMAN OTC DRUG LABEL	4
DOCUSATE SODIUM - A-S Medication Solutions	A-S Medication Solutions	2024-12-30	HUMAN OTC DRUG LABEL	1
DOCUSATE SODIUM - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	2024-11-21	HUMAN OTC DRUG LABEL	4
DRUG FACTS	WALMART INC. (see also Equate)	2024-06-26	HUMAN OTC DRUG LABEL	2
DRUG FACTS	United Natural Foods, Inc. dba UNFI	2024-06-13	HUMAN OTC DRUG LABEL	3
Drug Facts	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2024-03-15	HUMAN OTC DRUG LABEL	2